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OK to Skip Pelvic Lymph Node Dissection in Cervical Cancer?
Results from the PHENIX-I trial support skipping pelvic lymphadenectomy in women with early cervical cancer who have a negative sentinel lymph node biopsy.
Omitting pelvic lymphadenectomy in these patients “did not compromise disease-free survival and potentially [led to] improved overall survival,” reported lead investigator Jihong Liu, MD, gynecologic oncologist, Sun Yat-sen University Cancer Center, Guangzhou, China.
Forgoing the additional procedure also decreased the incidence of retroperitoneal lymph node recurrence and adverse events and demonstrated superior surgical outcomes including shorter operative duration, reduced blood loss, and a lower morbidity.
Liu reported the PHENIX-I results at this year’s Society of Gynecologic Oncology Annual Meeting on Women’s Cancers (SGO) 2025.
Pelvic lymphadenectomy has been part of standard care for early-stage cervical cancer for over a century, even though the incidence of lymph node metastasis in early-stage cervical cancer is relatively low. Overtreatment and increased morbidity have been notable drawbacks of the procedure.
It may be possible to forgo pelvic lymphadenectomy in early-stage cervical cancer when sentinel lymph node biopsy findings are negative, but evidence from randomized controlled trials are lacking, Liu explained.
The PHENIX-I trial prospectively assessed survival outcomes among patients who received pelvic lymphadenectomy and those who did not. More specifically, all patients underwent sentinel lymph node biopsy and patients with negative lymph nodes were then intraoperatively randomized (1:1) to undergo pelvic lymphadenectomy (417 patients) or not (416 patients).
The multicenter, randomized controlled trial involved patients undergoing radical hysterectomy for stage IA1 (lymphovascular invasion), IA2, IB1, IB2 or IIA1 cervical cancer with tumor size not exceeding 3 cm.
“The only difference between the two groups was that patients in the experimental arm did not have pelvic lymphadenectomy,” Liu said.
Liu and colleagues reported that 23 patients (2.8%) had a positive lymph node on postoperative pathology examination. The rate of false-negative sentinel lymph node biopsy was < 1%. About half the patients in both groups received postoperative adjuvant therapy, and there was no significant between-group difference in the rates and time to initiate adjuvant therapy.
Overall, about 3.85% of patients (n = 16) in the biopsy-only group had a recurrence compared with 6.24% (n = 26) in the pelvic lymphadenectomy group at a median follow-up of 50 months.
But no patients in the biopsy-only group had a recurrence in the retroperitoneal lymph nodes compared with 9 patients in the pelvic lymphadenectomy group.
The 3-year disease-free survival (primary endpoint) rates were similar between the two groups — 96.8% in the biopsy-only group and 94.5% in the lymphadenectomy group (hazard ratio [HR], 0.61; P = .12). However, the 3-year overall survival was significantly higher in biopsy-only group — 100% vs 97.8% in the lymphadenectomy group (HR, 0.21; P = .007). Overall, three patients (19%) in the biopsy-only group died from cervical cancer vs 14 (54%) in the lymphadenectomy group.
As for surgical complications, pelvic lymphadenectomy was associated with a higher incidence of pain (5.8% vs 1.7%), lymphocyst (22.1% vs 8.4%), and lymphedema (10.1% vs 2.4%), as well as longer operating time and more blood loss.
Offering perspective on PHENIX-I, discussant Premal Thaker, MD, noted that this is the first randomized trial to report on the use of sentinel lymph node biopsy alone vs biopsy plus pelvic lymphadenectomy after radical hysterectomy.
Key takeaways are the “equivalent” 3-year disease-free outcomes but “lower” overall survival in the pelvic lymphadenectomy group as well as more adverse events, said Thaker, gynecologic oncologist and surgeon, Siteman Cancer Center, Washington University, St Louis.
Although quality of life data was not presented in the trial, patients who skipped pelvic lymphadenectomy had fewer adverse events, “which is very important for our patients,” Thaker added.
This study had no commercial funding. Liu and Thaker had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Results from the PHENIX-I trial support skipping pelvic lymphadenectomy in women with early cervical cancer who have a negative sentinel lymph node biopsy.
Omitting pelvic lymphadenectomy in these patients “did not compromise disease-free survival and potentially [led to] improved overall survival,” reported lead investigator Jihong Liu, MD, gynecologic oncologist, Sun Yat-sen University Cancer Center, Guangzhou, China.
Forgoing the additional procedure also decreased the incidence of retroperitoneal lymph node recurrence and adverse events and demonstrated superior surgical outcomes including shorter operative duration, reduced blood loss, and a lower morbidity.
Liu reported the PHENIX-I results at this year’s Society of Gynecologic Oncology Annual Meeting on Women’s Cancers (SGO) 2025.
Pelvic lymphadenectomy has been part of standard care for early-stage cervical cancer for over a century, even though the incidence of lymph node metastasis in early-stage cervical cancer is relatively low. Overtreatment and increased morbidity have been notable drawbacks of the procedure.
It may be possible to forgo pelvic lymphadenectomy in early-stage cervical cancer when sentinel lymph node biopsy findings are negative, but evidence from randomized controlled trials are lacking, Liu explained.
The PHENIX-I trial prospectively assessed survival outcomes among patients who received pelvic lymphadenectomy and those who did not. More specifically, all patients underwent sentinel lymph node biopsy and patients with negative lymph nodes were then intraoperatively randomized (1:1) to undergo pelvic lymphadenectomy (417 patients) or not (416 patients).
The multicenter, randomized controlled trial involved patients undergoing radical hysterectomy for stage IA1 (lymphovascular invasion), IA2, IB1, IB2 or IIA1 cervical cancer with tumor size not exceeding 3 cm.
“The only difference between the two groups was that patients in the experimental arm did not have pelvic lymphadenectomy,” Liu said.
Liu and colleagues reported that 23 patients (2.8%) had a positive lymph node on postoperative pathology examination. The rate of false-negative sentinel lymph node biopsy was < 1%. About half the patients in both groups received postoperative adjuvant therapy, and there was no significant between-group difference in the rates and time to initiate adjuvant therapy.
Overall, about 3.85% of patients (n = 16) in the biopsy-only group had a recurrence compared with 6.24% (n = 26) in the pelvic lymphadenectomy group at a median follow-up of 50 months.
But no patients in the biopsy-only group had a recurrence in the retroperitoneal lymph nodes compared with 9 patients in the pelvic lymphadenectomy group.
The 3-year disease-free survival (primary endpoint) rates were similar between the two groups — 96.8% in the biopsy-only group and 94.5% in the lymphadenectomy group (hazard ratio [HR], 0.61; P = .12). However, the 3-year overall survival was significantly higher in biopsy-only group — 100% vs 97.8% in the lymphadenectomy group (HR, 0.21; P = .007). Overall, three patients (19%) in the biopsy-only group died from cervical cancer vs 14 (54%) in the lymphadenectomy group.
As for surgical complications, pelvic lymphadenectomy was associated with a higher incidence of pain (5.8% vs 1.7%), lymphocyst (22.1% vs 8.4%), and lymphedema (10.1% vs 2.4%), as well as longer operating time and more blood loss.
Offering perspective on PHENIX-I, discussant Premal Thaker, MD, noted that this is the first randomized trial to report on the use of sentinel lymph node biopsy alone vs biopsy plus pelvic lymphadenectomy after radical hysterectomy.
Key takeaways are the “equivalent” 3-year disease-free outcomes but “lower” overall survival in the pelvic lymphadenectomy group as well as more adverse events, said Thaker, gynecologic oncologist and surgeon, Siteman Cancer Center, Washington University, St Louis.
Although quality of life data was not presented in the trial, patients who skipped pelvic lymphadenectomy had fewer adverse events, “which is very important for our patients,” Thaker added.
This study had no commercial funding. Liu and Thaker had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Results from the PHENIX-I trial support skipping pelvic lymphadenectomy in women with early cervical cancer who have a negative sentinel lymph node biopsy.
Omitting pelvic lymphadenectomy in these patients “did not compromise disease-free survival and potentially [led to] improved overall survival,” reported lead investigator Jihong Liu, MD, gynecologic oncologist, Sun Yat-sen University Cancer Center, Guangzhou, China.
Forgoing the additional procedure also decreased the incidence of retroperitoneal lymph node recurrence and adverse events and demonstrated superior surgical outcomes including shorter operative duration, reduced blood loss, and a lower morbidity.
Liu reported the PHENIX-I results at this year’s Society of Gynecologic Oncology Annual Meeting on Women’s Cancers (SGO) 2025.
Pelvic lymphadenectomy has been part of standard care for early-stage cervical cancer for over a century, even though the incidence of lymph node metastasis in early-stage cervical cancer is relatively low. Overtreatment and increased morbidity have been notable drawbacks of the procedure.
It may be possible to forgo pelvic lymphadenectomy in early-stage cervical cancer when sentinel lymph node biopsy findings are negative, but evidence from randomized controlled trials are lacking, Liu explained.
The PHENIX-I trial prospectively assessed survival outcomes among patients who received pelvic lymphadenectomy and those who did not. More specifically, all patients underwent sentinel lymph node biopsy and patients with negative lymph nodes were then intraoperatively randomized (1:1) to undergo pelvic lymphadenectomy (417 patients) or not (416 patients).
The multicenter, randomized controlled trial involved patients undergoing radical hysterectomy for stage IA1 (lymphovascular invasion), IA2, IB1, IB2 or IIA1 cervical cancer with tumor size not exceeding 3 cm.
“The only difference between the two groups was that patients in the experimental arm did not have pelvic lymphadenectomy,” Liu said.
Liu and colleagues reported that 23 patients (2.8%) had a positive lymph node on postoperative pathology examination. The rate of false-negative sentinel lymph node biopsy was < 1%. About half the patients in both groups received postoperative adjuvant therapy, and there was no significant between-group difference in the rates and time to initiate adjuvant therapy.
Overall, about 3.85% of patients (n = 16) in the biopsy-only group had a recurrence compared with 6.24% (n = 26) in the pelvic lymphadenectomy group at a median follow-up of 50 months.
But no patients in the biopsy-only group had a recurrence in the retroperitoneal lymph nodes compared with 9 patients in the pelvic lymphadenectomy group.
The 3-year disease-free survival (primary endpoint) rates were similar between the two groups — 96.8% in the biopsy-only group and 94.5% in the lymphadenectomy group (hazard ratio [HR], 0.61; P = .12). However, the 3-year overall survival was significantly higher in biopsy-only group — 100% vs 97.8% in the lymphadenectomy group (HR, 0.21; P = .007). Overall, three patients (19%) in the biopsy-only group died from cervical cancer vs 14 (54%) in the lymphadenectomy group.
As for surgical complications, pelvic lymphadenectomy was associated with a higher incidence of pain (5.8% vs 1.7%), lymphocyst (22.1% vs 8.4%), and lymphedema (10.1% vs 2.4%), as well as longer operating time and more blood loss.
Offering perspective on PHENIX-I, discussant Premal Thaker, MD, noted that this is the first randomized trial to report on the use of sentinel lymph node biopsy alone vs biopsy plus pelvic lymphadenectomy after radical hysterectomy.
Key takeaways are the “equivalent” 3-year disease-free outcomes but “lower” overall survival in the pelvic lymphadenectomy group as well as more adverse events, said Thaker, gynecologic oncologist and surgeon, Siteman Cancer Center, Washington University, St Louis.
Although quality of life data was not presented in the trial, patients who skipped pelvic lymphadenectomy had fewer adverse events, “which is very important for our patients,” Thaker added.
This study had no commercial funding. Liu and Thaker had no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM SGO 2025
ACG Issues First Guidance on Diagnosis and Management of Gastric Premalignant Conditions
including atrophic gastritis, gastric intestinal metaplasia, dysplasia, and certain gastric epithelial polyps, all of which have an increased risk of progressing to gastric cancer.
The guideline was published online in The American Journal of Gastroenterology.
GPMCs are “common in gastroenterology practices, but in the US, at least, we’ve not had concrete guidance,” first author Douglas Morgan, MD, MPH, AGAF, Division of Gastroenterology, The University of Alabama at Birmingham, noted in an interview.
With these guidelines, we hope there “will be a paradigm shift to finally establish surveillance in the stomach, much like we’ve been doing for decades in the colon and the esophagus,” Morgan said.
Gastric cancer is a common cancer in the United States with disproportionately higher incidence rates in immigrants from countries with a high incidence of gastric cancer and certain non-White populations.
In addition, the 5-year survival rate in the United States for gastric cancer is 36%, which falls short of global standards and is driven by the fact that only a small percentage of these cancers are diagnosed in the early, curable stage.
These guidelines will help address this marked disparity and the burden on minority and marginalized populations, the guideline authors wrote. “The overarching goals are to reduce [gastric cancer] incidence in the United States, increase the detection of early-stage disease (early gastric cancer), and to significantly increase the 5-year survival rates in the near term.”
Key Recommendations
The guideline includes recommendations on endoscopic surveillance for high-risk patients, the performance of high-quality endoscopy and image-enhanced endoscopy (IEE) for diagnosis and surveillance, GPMC histology criteria and reporting, endoscopic treatment of dysplasia, the role of Helicobacter pylori eradication, general risk reduction measures, and the management of autoimmune gastritis and gastric epithelial polyps.
In terms of screening, the guidelines recommend against routine upper endoscopy screening for gastric cancer and GPMC in the general US population (low quality of evidence; conditional recommendation).
They also noted that there is “insufficient” direct US evidence to make a recommendation on opportunistic endoscopy screening for gastric cancer and GPMC in patients deemed at high risk based on race/ethnicity and family history. In addition, they recommend against the use of noninvasive biomarkers for screening or surveillance of GPMC or gastric cancer.
In terms of endoscopic and histologic diagnosis of GPMC, high-quality endoscopic evaluation is crucial to detect premalignant conditions or gastric cancer, the authors said. This includes adequate mucosal cleansing and insufflation, and photodocumentation of anatomic landmarks, as well as use of high-definition white light endoscopy (HDWLE) and IEE.
Systematic gastric biopsies should follow the updated Sydney protocol, with at least two separate containers for antrum/incisura and corpus biopsies. Histology should document the subtype of gastric intestinal metaplasia — incomplete, complete, or mixed — and severity and extent of atrophic gastritis and metaplasia.
Morgan emphasized the importance of coordination between the gastroenterologist and pathologist. “Several of these measures are not routinely reported, so we need to be in conversations with our collaborating pathologists,” he told this news organization.
In terms of GPMC surveillance, the authors suggest surveillance endoscopy every 3 years in high-risk patients with gastric intestinal metaplasia who meet one of the following criteria: High-risk histology (incomplete vs complete subtype, extending into the corpus); family history of gastric cancer in a first-degree relative; foreign-born individuals from high-gastric cancer incidence nations; or high-risk race/ethnicity (East Asian, Latino/a, Black, American Indian, or Alaska Native).
Individuals with multiple risk factors for gastric cancer may be considered for shorter than 3-year intervals.
Low-risk gastric intestinal metaplasia (limited to antrum, mild atrophy, and complete gastric intestinal metaplasia subtype) does not require routine endoscopic surveillance.
In terms of endoscopic management of dysplastic GPMC, endoscopic resection is suggested for dysplasia with visible margins. If dysplasia is not visible, repeat endoscopy with HDWLE and IEE by an experienced endoscopist is advised.
In patients appropriate for endoscopic resection of dysplasia, particularly endoscopic submucosal dissection, referral to a high-volume center with appropriate expertise in the diagnosis and therapeutic resection of gastric neoplasia is strongly recommended.
In patients with confirmed complete resection of dysplasia, endoscopic surveillance is also strongly recommended. Surveillance examinations should be performed by an experienced endoscopist using HDWLE and IEE, with biopsies according to the systematic biopsy protocol in addition to targeted biopsies.
In terms of nonendoscopic GPMC management, testing for H pylori (and eradication treatment if possible) is strongly recommended for patients with GPMC and those with a history of resected early gastric cancer.
Aspirin, nonsteroidal anti-inflammatory drugs, cyclooxygenase 2 inhibitors, or antioxidants are not recommended for patients with GPMC for the purpose of preventing gastric cancer.
In patients with autoimmune gastritis, testing for H pylori with a nonserological test, eradication treatment if positive, and posttreatment testing to confirm eradication is advised.
There is not enough evidence to make a formal recommendation on endoscopic surveillance in those with autoimmune gastritis; surveillance should be individualized, considering the risk for neuroendocrine tumors and possibly gastric cancer.
In terms of gastric epithelial polyps, endoscopic resection of all gastric adenomas is recommended, regardless of size, to exclude or prevent dysplasia and early gastric cancer. Adenomas that are not amenable to endoscopic resection should be referred for surgical resection, if clinically appropriate.
Morgan noted that the ACG GPMC guideline aligns with the updated ACG/American Society for Gastrointestinal Endoscopy upper endoscopy quality indicators released earlier this year.
Implementation of the ACG GPMC guideline and “change in clinical practice will require concrete targets and include training and quality initiatives,” the authors said.
This research received no commercial support. Morgan disclosed research support from Panbela Therapeutics, Thorne, and American Molecular Laboratories.
A version of this article first appeared on Medscape.com.
including atrophic gastritis, gastric intestinal metaplasia, dysplasia, and certain gastric epithelial polyps, all of which have an increased risk of progressing to gastric cancer.
The guideline was published online in The American Journal of Gastroenterology.
GPMCs are “common in gastroenterology practices, but in the US, at least, we’ve not had concrete guidance,” first author Douglas Morgan, MD, MPH, AGAF, Division of Gastroenterology, The University of Alabama at Birmingham, noted in an interview.
With these guidelines, we hope there “will be a paradigm shift to finally establish surveillance in the stomach, much like we’ve been doing for decades in the colon and the esophagus,” Morgan said.
Gastric cancer is a common cancer in the United States with disproportionately higher incidence rates in immigrants from countries with a high incidence of gastric cancer and certain non-White populations.
In addition, the 5-year survival rate in the United States for gastric cancer is 36%, which falls short of global standards and is driven by the fact that only a small percentage of these cancers are diagnosed in the early, curable stage.
These guidelines will help address this marked disparity and the burden on minority and marginalized populations, the guideline authors wrote. “The overarching goals are to reduce [gastric cancer] incidence in the United States, increase the detection of early-stage disease (early gastric cancer), and to significantly increase the 5-year survival rates in the near term.”
Key Recommendations
The guideline includes recommendations on endoscopic surveillance for high-risk patients, the performance of high-quality endoscopy and image-enhanced endoscopy (IEE) for diagnosis and surveillance, GPMC histology criteria and reporting, endoscopic treatment of dysplasia, the role of Helicobacter pylori eradication, general risk reduction measures, and the management of autoimmune gastritis and gastric epithelial polyps.
In terms of screening, the guidelines recommend against routine upper endoscopy screening for gastric cancer and GPMC in the general US population (low quality of evidence; conditional recommendation).
They also noted that there is “insufficient” direct US evidence to make a recommendation on opportunistic endoscopy screening for gastric cancer and GPMC in patients deemed at high risk based on race/ethnicity and family history. In addition, they recommend against the use of noninvasive biomarkers for screening or surveillance of GPMC or gastric cancer.
In terms of endoscopic and histologic diagnosis of GPMC, high-quality endoscopic evaluation is crucial to detect premalignant conditions or gastric cancer, the authors said. This includes adequate mucosal cleansing and insufflation, and photodocumentation of anatomic landmarks, as well as use of high-definition white light endoscopy (HDWLE) and IEE.
Systematic gastric biopsies should follow the updated Sydney protocol, with at least two separate containers for antrum/incisura and corpus biopsies. Histology should document the subtype of gastric intestinal metaplasia — incomplete, complete, or mixed — and severity and extent of atrophic gastritis and metaplasia.
Morgan emphasized the importance of coordination between the gastroenterologist and pathologist. “Several of these measures are not routinely reported, so we need to be in conversations with our collaborating pathologists,” he told this news organization.
In terms of GPMC surveillance, the authors suggest surveillance endoscopy every 3 years in high-risk patients with gastric intestinal metaplasia who meet one of the following criteria: High-risk histology (incomplete vs complete subtype, extending into the corpus); family history of gastric cancer in a first-degree relative; foreign-born individuals from high-gastric cancer incidence nations; or high-risk race/ethnicity (East Asian, Latino/a, Black, American Indian, or Alaska Native).
Individuals with multiple risk factors for gastric cancer may be considered for shorter than 3-year intervals.
Low-risk gastric intestinal metaplasia (limited to antrum, mild atrophy, and complete gastric intestinal metaplasia subtype) does not require routine endoscopic surveillance.
In terms of endoscopic management of dysplastic GPMC, endoscopic resection is suggested for dysplasia with visible margins. If dysplasia is not visible, repeat endoscopy with HDWLE and IEE by an experienced endoscopist is advised.
In patients appropriate for endoscopic resection of dysplasia, particularly endoscopic submucosal dissection, referral to a high-volume center with appropriate expertise in the diagnosis and therapeutic resection of gastric neoplasia is strongly recommended.
In patients with confirmed complete resection of dysplasia, endoscopic surveillance is also strongly recommended. Surveillance examinations should be performed by an experienced endoscopist using HDWLE and IEE, with biopsies according to the systematic biopsy protocol in addition to targeted biopsies.
In terms of nonendoscopic GPMC management, testing for H pylori (and eradication treatment if possible) is strongly recommended for patients with GPMC and those with a history of resected early gastric cancer.
Aspirin, nonsteroidal anti-inflammatory drugs, cyclooxygenase 2 inhibitors, or antioxidants are not recommended for patients with GPMC for the purpose of preventing gastric cancer.
In patients with autoimmune gastritis, testing for H pylori with a nonserological test, eradication treatment if positive, and posttreatment testing to confirm eradication is advised.
There is not enough evidence to make a formal recommendation on endoscopic surveillance in those with autoimmune gastritis; surveillance should be individualized, considering the risk for neuroendocrine tumors and possibly gastric cancer.
In terms of gastric epithelial polyps, endoscopic resection of all gastric adenomas is recommended, regardless of size, to exclude or prevent dysplasia and early gastric cancer. Adenomas that are not amenable to endoscopic resection should be referred for surgical resection, if clinically appropriate.
Morgan noted that the ACG GPMC guideline aligns with the updated ACG/American Society for Gastrointestinal Endoscopy upper endoscopy quality indicators released earlier this year.
Implementation of the ACG GPMC guideline and “change in clinical practice will require concrete targets and include training and quality initiatives,” the authors said.
This research received no commercial support. Morgan disclosed research support from Panbela Therapeutics, Thorne, and American Molecular Laboratories.
A version of this article first appeared on Medscape.com.
including atrophic gastritis, gastric intestinal metaplasia, dysplasia, and certain gastric epithelial polyps, all of which have an increased risk of progressing to gastric cancer.
The guideline was published online in The American Journal of Gastroenterology.
GPMCs are “common in gastroenterology practices, but in the US, at least, we’ve not had concrete guidance,” first author Douglas Morgan, MD, MPH, AGAF, Division of Gastroenterology, The University of Alabama at Birmingham, noted in an interview.
With these guidelines, we hope there “will be a paradigm shift to finally establish surveillance in the stomach, much like we’ve been doing for decades in the colon and the esophagus,” Morgan said.
Gastric cancer is a common cancer in the United States with disproportionately higher incidence rates in immigrants from countries with a high incidence of gastric cancer and certain non-White populations.
In addition, the 5-year survival rate in the United States for gastric cancer is 36%, which falls short of global standards and is driven by the fact that only a small percentage of these cancers are diagnosed in the early, curable stage.
These guidelines will help address this marked disparity and the burden on minority and marginalized populations, the guideline authors wrote. “The overarching goals are to reduce [gastric cancer] incidence in the United States, increase the detection of early-stage disease (early gastric cancer), and to significantly increase the 5-year survival rates in the near term.”
Key Recommendations
The guideline includes recommendations on endoscopic surveillance for high-risk patients, the performance of high-quality endoscopy and image-enhanced endoscopy (IEE) for diagnosis and surveillance, GPMC histology criteria and reporting, endoscopic treatment of dysplasia, the role of Helicobacter pylori eradication, general risk reduction measures, and the management of autoimmune gastritis and gastric epithelial polyps.
In terms of screening, the guidelines recommend against routine upper endoscopy screening for gastric cancer and GPMC in the general US population (low quality of evidence; conditional recommendation).
They also noted that there is “insufficient” direct US evidence to make a recommendation on opportunistic endoscopy screening for gastric cancer and GPMC in patients deemed at high risk based on race/ethnicity and family history. In addition, they recommend against the use of noninvasive biomarkers for screening or surveillance of GPMC or gastric cancer.
In terms of endoscopic and histologic diagnosis of GPMC, high-quality endoscopic evaluation is crucial to detect premalignant conditions or gastric cancer, the authors said. This includes adequate mucosal cleansing and insufflation, and photodocumentation of anatomic landmarks, as well as use of high-definition white light endoscopy (HDWLE) and IEE.
Systematic gastric biopsies should follow the updated Sydney protocol, with at least two separate containers for antrum/incisura and corpus biopsies. Histology should document the subtype of gastric intestinal metaplasia — incomplete, complete, or mixed — and severity and extent of atrophic gastritis and metaplasia.
Morgan emphasized the importance of coordination between the gastroenterologist and pathologist. “Several of these measures are not routinely reported, so we need to be in conversations with our collaborating pathologists,” he told this news organization.
In terms of GPMC surveillance, the authors suggest surveillance endoscopy every 3 years in high-risk patients with gastric intestinal metaplasia who meet one of the following criteria: High-risk histology (incomplete vs complete subtype, extending into the corpus); family history of gastric cancer in a first-degree relative; foreign-born individuals from high-gastric cancer incidence nations; or high-risk race/ethnicity (East Asian, Latino/a, Black, American Indian, or Alaska Native).
Individuals with multiple risk factors for gastric cancer may be considered for shorter than 3-year intervals.
Low-risk gastric intestinal metaplasia (limited to antrum, mild atrophy, and complete gastric intestinal metaplasia subtype) does not require routine endoscopic surveillance.
In terms of endoscopic management of dysplastic GPMC, endoscopic resection is suggested for dysplasia with visible margins. If dysplasia is not visible, repeat endoscopy with HDWLE and IEE by an experienced endoscopist is advised.
In patients appropriate for endoscopic resection of dysplasia, particularly endoscopic submucosal dissection, referral to a high-volume center with appropriate expertise in the diagnosis and therapeutic resection of gastric neoplasia is strongly recommended.
In patients with confirmed complete resection of dysplasia, endoscopic surveillance is also strongly recommended. Surveillance examinations should be performed by an experienced endoscopist using HDWLE and IEE, with biopsies according to the systematic biopsy protocol in addition to targeted biopsies.
In terms of nonendoscopic GPMC management, testing for H pylori (and eradication treatment if possible) is strongly recommended for patients with GPMC and those with a history of resected early gastric cancer.
Aspirin, nonsteroidal anti-inflammatory drugs, cyclooxygenase 2 inhibitors, or antioxidants are not recommended for patients with GPMC for the purpose of preventing gastric cancer.
In patients with autoimmune gastritis, testing for H pylori with a nonserological test, eradication treatment if positive, and posttreatment testing to confirm eradication is advised.
There is not enough evidence to make a formal recommendation on endoscopic surveillance in those with autoimmune gastritis; surveillance should be individualized, considering the risk for neuroendocrine tumors and possibly gastric cancer.
In terms of gastric epithelial polyps, endoscopic resection of all gastric adenomas is recommended, regardless of size, to exclude or prevent dysplasia and early gastric cancer. Adenomas that are not amenable to endoscopic resection should be referred for surgical resection, if clinically appropriate.
Morgan noted that the ACG GPMC guideline aligns with the updated ACG/American Society for Gastrointestinal Endoscopy upper endoscopy quality indicators released earlier this year.
Implementation of the ACG GPMC guideline and “change in clinical practice will require concrete targets and include training and quality initiatives,” the authors said.
This research received no commercial support. Morgan disclosed research support from Panbela Therapeutics, Thorne, and American Molecular Laboratories.
A version of this article first appeared on Medscape.com.
AI-Enhanced Echocardiography: A Game-Changer for Opportunistic Liver Disease Detection?
An AI algorithm called EchoNet-Liver demonstrated strong performance for detecting cirrhosis and steatotic liver disease (SLD) from routinely acquired transthoracic echocardiography studies containing subcostal images of the liver, the developers reported in NEJM AI.
“We hope that this algorithm enables physicians to opportunistically screen for chronic liver disease to identify asymptomatic and undiagnosed patients, thus enabling us to treat comorbidities relevant to the patient’s cardiovascular and noncardiovascular health,” Alan C. Kwan, MD, assistant professor, Department of Cardiology, Smidt Heart Institute at Cedars-Sinai, Los Angeles, California, told this news organization.
Harnessing Echo to Reveal Liver Trouble
CLD affects over 1.5 billion people globally, with many cases remaining undiagnosed due to the asymptomatic nature of early disease and a lack of routine screening. Traditional diagnostic methods such as liver function tests, ultrasonography, and MRI are often limited by cost, availability, and patient access.
Echocardiography is a commonly performed imaging study that incidentally captures images of the liver but is not utilized for liver disease assessment.
EchoNet-Liver is an AI algorithm that can identify high-quality subcostal images from full echocardiography studies and detect the presence of cirrhosis and SLD.
Kwan and colleagues trained it using nearly 1.6 million echocardiogram videos from 66,922 studies and 24,276 adult patients at Cedars-Sinai Medical Center (CSMC). The model predictions were compared with diagnoses from clinical evaluations of paired abdominal ultrasound or MRI studies. External validation studies were conducted using similar data from Stanford Health Care.
In the “held-out” CSMC ultrasound dataset, EchoNet-Liver detected cirrhosis with an area under the receiver operating characteristic curve (AUROC) of 0.837 (95% CI, 0.828-0.848) and SLD with an AUROC of 0.799 (95% CI, 0.788-0.811).
The algorithm showed a sensitivity of 69.6% and a specificity of 84.6% for detecting cirrhosis, and a sensitivity of 74.1% and a specificity of 72.0% for detecting SLD.
In the Stanford Health Care external-validation test ultrasound cohort, the model detected cirrhosis with an AUROC of 0.830 (95% CI, 0.799-0.859) and SLD with an AUROC of 0.769 (95% CI, 0.733-0.813), with sensitivity and specificity of 80.0% and 70.9%, respectively, for cirrhosis and 66.7% and 78.0%, respectively, for SLD.
In the CSMC MRI-paired cohort, EchoNet-Liver detected cirrhosis with an AUROC of 0.704 (95% CI, 0.699-0.708) and SLD with an AUROC of 0.725 (95% CI, 0.707-0.762).
Identifying Subclinical Liver Disease to Improve Outcomes
“Across diverse populations and disease definitions, deep-learning-enhanced echocardiography enabled high-throughput, automated detection of CLD, which could enable opportunistic screening for asymptomatic liver disease,” the authors wrote.
“By improving the diagnosis of subclinical CLD, we may be able to limit or reverse disease progression and improve care by triaging patients toward appropriate clinical and diagnostic management,” they said.
By way of limitations, the researchers noted that the tool was developed using a cohort of patients who had both abdominal ultrasound and echocardiography within 30 days, and thus probably had a higher prevalence of liver disease compared with the general population receiving echocardiography. The true clinical utility of EchoNet-Liver will depend on whether its application to a general echocardiography population can efficiently detect undiagnosed CLD, they cautioned.
“While we developed this algorithm based on clinical data, the application within the clinic would typically require FDA approval, which we have not yet applied for,” Kwan told this news organization.
“We plan to prospectively validate this algorithm at multiple sites to ensure that application of this algorithm improves patient care without causing excess diagnostic testing, thus providing value to patients and the healthcare system as a whole,” Kwan said.
Funding was provided in part by KAKENHI (Japan Society for the Promotion of Science). Kwan reported receiving consulting fees from InVision.
A version of this article first appeared on Medscape.com.
An AI algorithm called EchoNet-Liver demonstrated strong performance for detecting cirrhosis and steatotic liver disease (SLD) from routinely acquired transthoracic echocardiography studies containing subcostal images of the liver, the developers reported in NEJM AI.
“We hope that this algorithm enables physicians to opportunistically screen for chronic liver disease to identify asymptomatic and undiagnosed patients, thus enabling us to treat comorbidities relevant to the patient’s cardiovascular and noncardiovascular health,” Alan C. Kwan, MD, assistant professor, Department of Cardiology, Smidt Heart Institute at Cedars-Sinai, Los Angeles, California, told this news organization.
Harnessing Echo to Reveal Liver Trouble
CLD affects over 1.5 billion people globally, with many cases remaining undiagnosed due to the asymptomatic nature of early disease and a lack of routine screening. Traditional diagnostic methods such as liver function tests, ultrasonography, and MRI are often limited by cost, availability, and patient access.
Echocardiography is a commonly performed imaging study that incidentally captures images of the liver but is not utilized for liver disease assessment.
EchoNet-Liver is an AI algorithm that can identify high-quality subcostal images from full echocardiography studies and detect the presence of cirrhosis and SLD.
Kwan and colleagues trained it using nearly 1.6 million echocardiogram videos from 66,922 studies and 24,276 adult patients at Cedars-Sinai Medical Center (CSMC). The model predictions were compared with diagnoses from clinical evaluations of paired abdominal ultrasound or MRI studies. External validation studies were conducted using similar data from Stanford Health Care.
In the “held-out” CSMC ultrasound dataset, EchoNet-Liver detected cirrhosis with an area under the receiver operating characteristic curve (AUROC) of 0.837 (95% CI, 0.828-0.848) and SLD with an AUROC of 0.799 (95% CI, 0.788-0.811).
The algorithm showed a sensitivity of 69.6% and a specificity of 84.6% for detecting cirrhosis, and a sensitivity of 74.1% and a specificity of 72.0% for detecting SLD.
In the Stanford Health Care external-validation test ultrasound cohort, the model detected cirrhosis with an AUROC of 0.830 (95% CI, 0.799-0.859) and SLD with an AUROC of 0.769 (95% CI, 0.733-0.813), with sensitivity and specificity of 80.0% and 70.9%, respectively, for cirrhosis and 66.7% and 78.0%, respectively, for SLD.
In the CSMC MRI-paired cohort, EchoNet-Liver detected cirrhosis with an AUROC of 0.704 (95% CI, 0.699-0.708) and SLD with an AUROC of 0.725 (95% CI, 0.707-0.762).
Identifying Subclinical Liver Disease to Improve Outcomes
“Across diverse populations and disease definitions, deep-learning-enhanced echocardiography enabled high-throughput, automated detection of CLD, which could enable opportunistic screening for asymptomatic liver disease,” the authors wrote.
“By improving the diagnosis of subclinical CLD, we may be able to limit or reverse disease progression and improve care by triaging patients toward appropriate clinical and diagnostic management,” they said.
By way of limitations, the researchers noted that the tool was developed using a cohort of patients who had both abdominal ultrasound and echocardiography within 30 days, and thus probably had a higher prevalence of liver disease compared with the general population receiving echocardiography. The true clinical utility of EchoNet-Liver will depend on whether its application to a general echocardiography population can efficiently detect undiagnosed CLD, they cautioned.
“While we developed this algorithm based on clinical data, the application within the clinic would typically require FDA approval, which we have not yet applied for,” Kwan told this news organization.
“We plan to prospectively validate this algorithm at multiple sites to ensure that application of this algorithm improves patient care without causing excess diagnostic testing, thus providing value to patients and the healthcare system as a whole,” Kwan said.
Funding was provided in part by KAKENHI (Japan Society for the Promotion of Science). Kwan reported receiving consulting fees from InVision.
A version of this article first appeared on Medscape.com.
An AI algorithm called EchoNet-Liver demonstrated strong performance for detecting cirrhosis and steatotic liver disease (SLD) from routinely acquired transthoracic echocardiography studies containing subcostal images of the liver, the developers reported in NEJM AI.
“We hope that this algorithm enables physicians to opportunistically screen for chronic liver disease to identify asymptomatic and undiagnosed patients, thus enabling us to treat comorbidities relevant to the patient’s cardiovascular and noncardiovascular health,” Alan C. Kwan, MD, assistant professor, Department of Cardiology, Smidt Heart Institute at Cedars-Sinai, Los Angeles, California, told this news organization.
Harnessing Echo to Reveal Liver Trouble
CLD affects over 1.5 billion people globally, with many cases remaining undiagnosed due to the asymptomatic nature of early disease and a lack of routine screening. Traditional diagnostic methods such as liver function tests, ultrasonography, and MRI are often limited by cost, availability, and patient access.
Echocardiography is a commonly performed imaging study that incidentally captures images of the liver but is not utilized for liver disease assessment.
EchoNet-Liver is an AI algorithm that can identify high-quality subcostal images from full echocardiography studies and detect the presence of cirrhosis and SLD.
Kwan and colleagues trained it using nearly 1.6 million echocardiogram videos from 66,922 studies and 24,276 adult patients at Cedars-Sinai Medical Center (CSMC). The model predictions were compared with diagnoses from clinical evaluations of paired abdominal ultrasound or MRI studies. External validation studies were conducted using similar data from Stanford Health Care.
In the “held-out” CSMC ultrasound dataset, EchoNet-Liver detected cirrhosis with an area under the receiver operating characteristic curve (AUROC) of 0.837 (95% CI, 0.828-0.848) and SLD with an AUROC of 0.799 (95% CI, 0.788-0.811).
The algorithm showed a sensitivity of 69.6% and a specificity of 84.6% for detecting cirrhosis, and a sensitivity of 74.1% and a specificity of 72.0% for detecting SLD.
In the Stanford Health Care external-validation test ultrasound cohort, the model detected cirrhosis with an AUROC of 0.830 (95% CI, 0.799-0.859) and SLD with an AUROC of 0.769 (95% CI, 0.733-0.813), with sensitivity and specificity of 80.0% and 70.9%, respectively, for cirrhosis and 66.7% and 78.0%, respectively, for SLD.
In the CSMC MRI-paired cohort, EchoNet-Liver detected cirrhosis with an AUROC of 0.704 (95% CI, 0.699-0.708) and SLD with an AUROC of 0.725 (95% CI, 0.707-0.762).
Identifying Subclinical Liver Disease to Improve Outcomes
“Across diverse populations and disease definitions, deep-learning-enhanced echocardiography enabled high-throughput, automated detection of CLD, which could enable opportunistic screening for asymptomatic liver disease,” the authors wrote.
“By improving the diagnosis of subclinical CLD, we may be able to limit or reverse disease progression and improve care by triaging patients toward appropriate clinical and diagnostic management,” they said.
By way of limitations, the researchers noted that the tool was developed using a cohort of patients who had both abdominal ultrasound and echocardiography within 30 days, and thus probably had a higher prevalence of liver disease compared with the general population receiving echocardiography. The true clinical utility of EchoNet-Liver will depend on whether its application to a general echocardiography population can efficiently detect undiagnosed CLD, they cautioned.
“While we developed this algorithm based on clinical data, the application within the clinic would typically require FDA approval, which we have not yet applied for,” Kwan told this news organization.
“We plan to prospectively validate this algorithm at multiple sites to ensure that application of this algorithm improves patient care without causing excess diagnostic testing, thus providing value to patients and the healthcare system as a whole,” Kwan said.
Funding was provided in part by KAKENHI (Japan Society for the Promotion of Science). Kwan reported receiving consulting fees from InVision.
A version of this article first appeared on Medscape.com.
Better Prep, Better Scope: Task Force Updates Colonoscopy Bowel Prep Advice
The latest consensus recommendations emphasize the importance of verbal and written patient education, refine diet restrictions, update optimal purgative regimens, and advise tracking bowel prep adequacy rates at both the individual endoscopist and unit levels.
“Colorectal cancer remains the second most common cause of cancer death in the United States, and colonoscopy is considered the gold standard for evaluating the colon, including assessing causes of colon-related signs or symptoms and the detection of precancerous lesions. It is well recognized that the adequacy of bowel preparation is essential for optimal colonoscopy performance,” the task force wrote.
Choice of Prep, Dosing and Timing, and Dietary Restrictions
When choosing bowel preparation regimens, the task force recommends considering the individual’s medical history, medications, and, when available, the adequacy of bowel preparation reported from prior colonoscopies. Other considerations include patient preference, associated additional costs to the patient, and ease in obtaining and consuming any purgatives or adjuncts.
In terms of timing and dose, the task force now “suggests that lower-volume bowel preparation regimens, such as those that rely on only 2 liters of fluid compared to the traditional 4L, are acceptable options for individuals considered unlikely to have an inadequate bowel preparation. This assumes that the purgative is taken in a split-dose fashion (half the evening prior to colonoscopy and half the morning of the colonoscopy),” co–lead author Brian C. Jacobson, MD, MPH, AGAF, with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.
The task force also states that a same-day bowel preparation regimen for afternoon, but not morning, colonoscopy is a “reasonable alternative to the now-common split-dose regimen,” Jacobson said.
The group did not find one bowel preparation purgative to be better than others, although table 7 in the document details characteristics of commonly used prep regimens including their side effects and contraindications.
Recommendations regarding dietary modifications depend upon the patient’s risk for inadequate bowel prep. For patients at low risk for inadequate bowel prep, the task force recommends limiting dietary restrictions to the day before a colonoscopy, relying on either clear liquids or low-fiber/low-residue diets for the early and midday meals. Table 5 in the document provides a list of low-residue foods and sample meals.
The task force also suggests the adjunctive use of oral simethicone (≥ 320 mg) to bowel prep as a way to potentially improve visualization, although they acknowledge that further research is needed.
How might these updated consensus recommendations change current clinical practice?
Jacobson said: “Some physicians may try to identify individuals who will do just as well with a more patient-friendly, easily tolerated bowel preparation regimen, including less stringent dietary restrictions leading up to colonoscopy.”
He noted that the task force prefers the term “guidance” to “guidelines.”
New Quality Benchmark
The task force recommends documenting bowel prep quality in the endoscopy report after all washing and suctioning have been completed using reliably understood descriptors that communicate the adequacy of the preparation.
They recommend the term “adequate bowel preparation” be used to indicate that standard screening or surveillance intervals can be assigned based on the findings of the colonoscopy.
Additionally, the task force recommends that endoscopy units and individual endoscopists track and aim for ≥ 90% adequacy rates in bowel preparation — up from the 85% benchmark contained in the prior recommendations.
Jacobson told this news organization it’s “currently unknown” how many individual endoscopists and endoscopy units track and meet the 90% benchmark at present.
David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who wasn’t on the task force, said endoscopy units and providers “need to be accountable and should be tracking this quality metric.”
Johnson noted that bowel prep inadequacy has “intrinsic costs,” impacting lesion detection, CRC incidence, and patient outcomes. Inadequate prep leads to “increased risk for morbidity, mortality, longer appointment and wait times for rescheduling, and negative connotations that may deter patients from returning.”
Brian Sullivan, MD, MHS, assistant professor of medicine, division of gastroenterology, Duke University School of Medicine, Durham, North Carolina, who wasn’t on the task force, said the recommendation to target a 90% or higher bowel preparation adequacy rate is “appreciated.”
“This benchmark encourages practices to standardize measurement, tracking, and reporting of preparation quality at both the individual and unit levels. Specifically, it should motivate providers to critically evaluate their interpretation of preparation quality and ensure adequate cleansing before making determinations,” Sullivan said in an interview.
“At the unit level, this metric can identify whether there are opportunities for quality improvement, such as by implementing evidence-based initiatives (provided in the guidance) to enhance outpatient preparation processes,” Sullivan noted.
The task force emphasized that the majority of consensus recommendations focus on individuals at average risk for inadequate bowel prep. Patients at high risk for inadequate bowel prep (eg, diabetes, constipation, opioid use) should receive tailored instructions, including a more extended dietary prep and high-volume purgatives.
‘Timely and Important’ Updates
Sullivan said the updated consensus recommendations on optimizing bowel preparation quality for colonoscopy are both “timely and important.”
“Clear guidance facilitates dissemination and adoption, promoting flexible yet evidence-based approaches that enhance patient and provider satisfaction while potentially improving CRC prevention outcomes. For instance, surveys reveal that some practices still do not utilize split-dose bowel preparation, which is proven to improve preparation quality, particularly for the right-side of the colon. This gap underscores the need for standardized guidance to ensure high-quality colonoscopy and effective CRC screening,” Sullivan said.
He also noted that the inclusion of lower-volume bowel prep regimens and less intensive dietary modifications for selected patients is a “welcome update.”
“These options can improve patient adherence and satisfaction, which are critical not only for the quality of the index exam but also for ensuring patients return for future screenings, thereby supporting long-term CRC prevention efforts,” Sullivan said.
The task force includes representatives from the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy.
The consensus document was published online in the three societies’ respective scientific journals — Gastroenterology, the American Journal of Gastroenterology, and Gastrointestinal Endsocopy.
This research had no financial support. Jacobson is a consultant for Curis and Guardant Health. Sullivan had no disclosures. Johnson is an adviser to ISOThrive and a past president of the American College of Gastroenterology.
A version of this article first appeared on Medscape.com.
The latest consensus recommendations emphasize the importance of verbal and written patient education, refine diet restrictions, update optimal purgative regimens, and advise tracking bowel prep adequacy rates at both the individual endoscopist and unit levels.
“Colorectal cancer remains the second most common cause of cancer death in the United States, and colonoscopy is considered the gold standard for evaluating the colon, including assessing causes of colon-related signs or symptoms and the detection of precancerous lesions. It is well recognized that the adequacy of bowel preparation is essential for optimal colonoscopy performance,” the task force wrote.
Choice of Prep, Dosing and Timing, and Dietary Restrictions
When choosing bowel preparation regimens, the task force recommends considering the individual’s medical history, medications, and, when available, the adequacy of bowel preparation reported from prior colonoscopies. Other considerations include patient preference, associated additional costs to the patient, and ease in obtaining and consuming any purgatives or adjuncts.
In terms of timing and dose, the task force now “suggests that lower-volume bowel preparation regimens, such as those that rely on only 2 liters of fluid compared to the traditional 4L, are acceptable options for individuals considered unlikely to have an inadequate bowel preparation. This assumes that the purgative is taken in a split-dose fashion (half the evening prior to colonoscopy and half the morning of the colonoscopy),” co–lead author Brian C. Jacobson, MD, MPH, AGAF, with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.
The task force also states that a same-day bowel preparation regimen for afternoon, but not morning, colonoscopy is a “reasonable alternative to the now-common split-dose regimen,” Jacobson said.
The group did not find one bowel preparation purgative to be better than others, although table 7 in the document details characteristics of commonly used prep regimens including their side effects and contraindications.
Recommendations regarding dietary modifications depend upon the patient’s risk for inadequate bowel prep. For patients at low risk for inadequate bowel prep, the task force recommends limiting dietary restrictions to the day before a colonoscopy, relying on either clear liquids or low-fiber/low-residue diets for the early and midday meals. Table 5 in the document provides a list of low-residue foods and sample meals.
The task force also suggests the adjunctive use of oral simethicone (≥ 320 mg) to bowel prep as a way to potentially improve visualization, although they acknowledge that further research is needed.
How might these updated consensus recommendations change current clinical practice?
Jacobson said: “Some physicians may try to identify individuals who will do just as well with a more patient-friendly, easily tolerated bowel preparation regimen, including less stringent dietary restrictions leading up to colonoscopy.”
He noted that the task force prefers the term “guidance” to “guidelines.”
New Quality Benchmark
The task force recommends documenting bowel prep quality in the endoscopy report after all washing and suctioning have been completed using reliably understood descriptors that communicate the adequacy of the preparation.
They recommend the term “adequate bowel preparation” be used to indicate that standard screening or surveillance intervals can be assigned based on the findings of the colonoscopy.
Additionally, the task force recommends that endoscopy units and individual endoscopists track and aim for ≥ 90% adequacy rates in bowel preparation — up from the 85% benchmark contained in the prior recommendations.
Jacobson told this news organization it’s “currently unknown” how many individual endoscopists and endoscopy units track and meet the 90% benchmark at present.
David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who wasn’t on the task force, said endoscopy units and providers “need to be accountable and should be tracking this quality metric.”
Johnson noted that bowel prep inadequacy has “intrinsic costs,” impacting lesion detection, CRC incidence, and patient outcomes. Inadequate prep leads to “increased risk for morbidity, mortality, longer appointment and wait times for rescheduling, and negative connotations that may deter patients from returning.”
Brian Sullivan, MD, MHS, assistant professor of medicine, division of gastroenterology, Duke University School of Medicine, Durham, North Carolina, who wasn’t on the task force, said the recommendation to target a 90% or higher bowel preparation adequacy rate is “appreciated.”
“This benchmark encourages practices to standardize measurement, tracking, and reporting of preparation quality at both the individual and unit levels. Specifically, it should motivate providers to critically evaluate their interpretation of preparation quality and ensure adequate cleansing before making determinations,” Sullivan said in an interview.
“At the unit level, this metric can identify whether there are opportunities for quality improvement, such as by implementing evidence-based initiatives (provided in the guidance) to enhance outpatient preparation processes,” Sullivan noted.
The task force emphasized that the majority of consensus recommendations focus on individuals at average risk for inadequate bowel prep. Patients at high risk for inadequate bowel prep (eg, diabetes, constipation, opioid use) should receive tailored instructions, including a more extended dietary prep and high-volume purgatives.
‘Timely and Important’ Updates
Sullivan said the updated consensus recommendations on optimizing bowel preparation quality for colonoscopy are both “timely and important.”
“Clear guidance facilitates dissemination and adoption, promoting flexible yet evidence-based approaches that enhance patient and provider satisfaction while potentially improving CRC prevention outcomes. For instance, surveys reveal that some practices still do not utilize split-dose bowel preparation, which is proven to improve preparation quality, particularly for the right-side of the colon. This gap underscores the need for standardized guidance to ensure high-quality colonoscopy and effective CRC screening,” Sullivan said.
He also noted that the inclusion of lower-volume bowel prep regimens and less intensive dietary modifications for selected patients is a “welcome update.”
“These options can improve patient adherence and satisfaction, which are critical not only for the quality of the index exam but also for ensuring patients return for future screenings, thereby supporting long-term CRC prevention efforts,” Sullivan said.
The task force includes representatives from the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy.
The consensus document was published online in the three societies’ respective scientific journals — Gastroenterology, the American Journal of Gastroenterology, and Gastrointestinal Endsocopy.
This research had no financial support. Jacobson is a consultant for Curis and Guardant Health. Sullivan had no disclosures. Johnson is an adviser to ISOThrive and a past president of the American College of Gastroenterology.
A version of this article first appeared on Medscape.com.
The latest consensus recommendations emphasize the importance of verbal and written patient education, refine diet restrictions, update optimal purgative regimens, and advise tracking bowel prep adequacy rates at both the individual endoscopist and unit levels.
“Colorectal cancer remains the second most common cause of cancer death in the United States, and colonoscopy is considered the gold standard for evaluating the colon, including assessing causes of colon-related signs or symptoms and the detection of precancerous lesions. It is well recognized that the adequacy of bowel preparation is essential for optimal colonoscopy performance,” the task force wrote.
Choice of Prep, Dosing and Timing, and Dietary Restrictions
When choosing bowel preparation regimens, the task force recommends considering the individual’s medical history, medications, and, when available, the adequacy of bowel preparation reported from prior colonoscopies. Other considerations include patient preference, associated additional costs to the patient, and ease in obtaining and consuming any purgatives or adjuncts.
In terms of timing and dose, the task force now “suggests that lower-volume bowel preparation regimens, such as those that rely on only 2 liters of fluid compared to the traditional 4L, are acceptable options for individuals considered unlikely to have an inadequate bowel preparation. This assumes that the purgative is taken in a split-dose fashion (half the evening prior to colonoscopy and half the morning of the colonoscopy),” co–lead author Brian C. Jacobson, MD, MPH, AGAF, with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.
The task force also states that a same-day bowel preparation regimen for afternoon, but not morning, colonoscopy is a “reasonable alternative to the now-common split-dose regimen,” Jacobson said.
The group did not find one bowel preparation purgative to be better than others, although table 7 in the document details characteristics of commonly used prep regimens including their side effects and contraindications.
Recommendations regarding dietary modifications depend upon the patient’s risk for inadequate bowel prep. For patients at low risk for inadequate bowel prep, the task force recommends limiting dietary restrictions to the day before a colonoscopy, relying on either clear liquids or low-fiber/low-residue diets for the early and midday meals. Table 5 in the document provides a list of low-residue foods and sample meals.
The task force also suggests the adjunctive use of oral simethicone (≥ 320 mg) to bowel prep as a way to potentially improve visualization, although they acknowledge that further research is needed.
How might these updated consensus recommendations change current clinical practice?
Jacobson said: “Some physicians may try to identify individuals who will do just as well with a more patient-friendly, easily tolerated bowel preparation regimen, including less stringent dietary restrictions leading up to colonoscopy.”
He noted that the task force prefers the term “guidance” to “guidelines.”
New Quality Benchmark
The task force recommends documenting bowel prep quality in the endoscopy report after all washing and suctioning have been completed using reliably understood descriptors that communicate the adequacy of the preparation.
They recommend the term “adequate bowel preparation” be used to indicate that standard screening or surveillance intervals can be assigned based on the findings of the colonoscopy.
Additionally, the task force recommends that endoscopy units and individual endoscopists track and aim for ≥ 90% adequacy rates in bowel preparation — up from the 85% benchmark contained in the prior recommendations.
Jacobson told this news organization it’s “currently unknown” how many individual endoscopists and endoscopy units track and meet the 90% benchmark at present.
David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who wasn’t on the task force, said endoscopy units and providers “need to be accountable and should be tracking this quality metric.”
Johnson noted that bowel prep inadequacy has “intrinsic costs,” impacting lesion detection, CRC incidence, and patient outcomes. Inadequate prep leads to “increased risk for morbidity, mortality, longer appointment and wait times for rescheduling, and negative connotations that may deter patients from returning.”
Brian Sullivan, MD, MHS, assistant professor of medicine, division of gastroenterology, Duke University School of Medicine, Durham, North Carolina, who wasn’t on the task force, said the recommendation to target a 90% or higher bowel preparation adequacy rate is “appreciated.”
“This benchmark encourages practices to standardize measurement, tracking, and reporting of preparation quality at both the individual and unit levels. Specifically, it should motivate providers to critically evaluate their interpretation of preparation quality and ensure adequate cleansing before making determinations,” Sullivan said in an interview.
“At the unit level, this metric can identify whether there are opportunities for quality improvement, such as by implementing evidence-based initiatives (provided in the guidance) to enhance outpatient preparation processes,” Sullivan noted.
The task force emphasized that the majority of consensus recommendations focus on individuals at average risk for inadequate bowel prep. Patients at high risk for inadequate bowel prep (eg, diabetes, constipation, opioid use) should receive tailored instructions, including a more extended dietary prep and high-volume purgatives.
‘Timely and Important’ Updates
Sullivan said the updated consensus recommendations on optimizing bowel preparation quality for colonoscopy are both “timely and important.”
“Clear guidance facilitates dissemination and adoption, promoting flexible yet evidence-based approaches that enhance patient and provider satisfaction while potentially improving CRC prevention outcomes. For instance, surveys reveal that some practices still do not utilize split-dose bowel preparation, which is proven to improve preparation quality, particularly for the right-side of the colon. This gap underscores the need for standardized guidance to ensure high-quality colonoscopy and effective CRC screening,” Sullivan said.
He also noted that the inclusion of lower-volume bowel prep regimens and less intensive dietary modifications for selected patients is a “welcome update.”
“These options can improve patient adherence and satisfaction, which are critical not only for the quality of the index exam but also for ensuring patients return for future screenings, thereby supporting long-term CRC prevention efforts,” Sullivan said.
The task force includes representatives from the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy.
The consensus document was published online in the three societies’ respective scientific journals — Gastroenterology, the American Journal of Gastroenterology, and Gastrointestinal Endsocopy.
This research had no financial support. Jacobson is a consultant for Curis and Guardant Health. Sullivan had no disclosures. Johnson is an adviser to ISOThrive and a past president of the American College of Gastroenterology.
A version of this article first appeared on Medscape.com.
FROM GASTROENTEROLOGY
HCV Screening Rates in Women Remain Low in the US
“We found that screening rates were higher and rose more steeply in pregnant individuals compared to nonpregnant reproductive age females after this guidance.” However overall, HCV screening in women still remained low by the end of 2022, authors Roshni Singh, MD, and Rachel Epstein, MD, MSc, with the section of infectious diseases, Boston Medical Center, noted in an email to this news organization.
The study was published online in JAMA.
The researchers leveraged TriNetX LIVE electronic health record data to compare HCV screening rates from 68 US healthcare organizations covering more than 115 million patients.
Using a multiple-group interrupted time series analysis, they compared HCV screening rates for pregnant and nonpregnant women for each 6-month period before (January 2014 to December 2019) and after (July 2020 to December 2022) the 2020 guidelines. January to June 2020 was considered a washout period to account for the COVID-19 pandemic peak and guideline dissemination.
For the entire 9-year study period (2014-2022), a total of 79,231 incident HCV tests occurred among pregnant women and 678,951 occurred among nonpregnant women.
In the 6 months before the guidance, HCV screening per 1000 person-years increased from 52 to 117 tests among pregnant women and 16 to 24 tests among nonpregnant women.
In the 6 months after the guidance, screening per 1000 person-years increased from 141 to 253 among pregnant women and from 29 to 37 among nonpregnant women.
Yet by the end of 2022, only 38.7% of women with a pregnancy and 8.7% of nonpregnant women were ever tested for the HCV.
How to Boost HCV Screening
These results suggest that “innovative strategies are needed to improve HCV diagnosis and treatment,” the authors wrote.
“Several interventions have been demonstrated to be effective in increasing screening in general, including electronic medical record alerts for opt-out testing, routine test offer by nonclinician office staff, offering testing in nontraditional spaces, including substance use treatment programs, harm reduction centers, STI clinics, and mobile health units,” Singh and Epstein told this news organization.
“A key step is educating primary care providers in addition to addiction medicine and emergency medicine clinicians about the updated guidelines as they interface with a large number of at-risk individuals,” they said. And the most important measure is creating clear work flows that respond to positive results to link people to treatment and cure.
“Clinicians need to feel empowered that their work screening a patient can make a meaningful difference in both the patient’s life and in helping end this epidemic,” the two researchers explained.
Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America, who wasn’t involved in the study, told this news organization that the low HCV screening rates are not surprising.
“We tend not to do well with screening. It’s not necessarily anybody’s fault, but patients don’t necessarily want to be screened. Sometimes physicians are very busy. Sometimes screening is not the most important thing for them to do. Sometimes there are processes in place that fall through,” said Glatt, chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau, Oceanside, New York.
“We tend to do a better job of screening in pregnant than nonpregnant women because pregnancy is a focus and there is 9 months that you can be following-up, so there is more opportunity. A healthy nonpregnant woman may not see her doctor for another year,” Glatt noted.
“I think that many physicians are very good at screening for hepatitis C in patients that are clearly at risk,” he added. “We’re not so good at screening for people” that don’t have a clear risk but do “have risk factors.”
The study had no commercial funding. Singh, Epstein, and Glatt had no relevant disclosures.
A version of this article first appeared on Medscape.com.
“We found that screening rates were higher and rose more steeply in pregnant individuals compared to nonpregnant reproductive age females after this guidance.” However overall, HCV screening in women still remained low by the end of 2022, authors Roshni Singh, MD, and Rachel Epstein, MD, MSc, with the section of infectious diseases, Boston Medical Center, noted in an email to this news organization.
The study was published online in JAMA.
The researchers leveraged TriNetX LIVE electronic health record data to compare HCV screening rates from 68 US healthcare organizations covering more than 115 million patients.
Using a multiple-group interrupted time series analysis, they compared HCV screening rates for pregnant and nonpregnant women for each 6-month period before (January 2014 to December 2019) and after (July 2020 to December 2022) the 2020 guidelines. January to June 2020 was considered a washout period to account for the COVID-19 pandemic peak and guideline dissemination.
For the entire 9-year study period (2014-2022), a total of 79,231 incident HCV tests occurred among pregnant women and 678,951 occurred among nonpregnant women.
In the 6 months before the guidance, HCV screening per 1000 person-years increased from 52 to 117 tests among pregnant women and 16 to 24 tests among nonpregnant women.
In the 6 months after the guidance, screening per 1000 person-years increased from 141 to 253 among pregnant women and from 29 to 37 among nonpregnant women.
Yet by the end of 2022, only 38.7% of women with a pregnancy and 8.7% of nonpregnant women were ever tested for the HCV.
How to Boost HCV Screening
These results suggest that “innovative strategies are needed to improve HCV diagnosis and treatment,” the authors wrote.
“Several interventions have been demonstrated to be effective in increasing screening in general, including electronic medical record alerts for opt-out testing, routine test offer by nonclinician office staff, offering testing in nontraditional spaces, including substance use treatment programs, harm reduction centers, STI clinics, and mobile health units,” Singh and Epstein told this news organization.
“A key step is educating primary care providers in addition to addiction medicine and emergency medicine clinicians about the updated guidelines as they interface with a large number of at-risk individuals,” they said. And the most important measure is creating clear work flows that respond to positive results to link people to treatment and cure.
“Clinicians need to feel empowered that their work screening a patient can make a meaningful difference in both the patient’s life and in helping end this epidemic,” the two researchers explained.
Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America, who wasn’t involved in the study, told this news organization that the low HCV screening rates are not surprising.
“We tend not to do well with screening. It’s not necessarily anybody’s fault, but patients don’t necessarily want to be screened. Sometimes physicians are very busy. Sometimes screening is not the most important thing for them to do. Sometimes there are processes in place that fall through,” said Glatt, chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau, Oceanside, New York.
“We tend to do a better job of screening in pregnant than nonpregnant women because pregnancy is a focus and there is 9 months that you can be following-up, so there is more opportunity. A healthy nonpregnant woman may not see her doctor for another year,” Glatt noted.
“I think that many physicians are very good at screening for hepatitis C in patients that are clearly at risk,” he added. “We’re not so good at screening for people” that don’t have a clear risk but do “have risk factors.”
The study had no commercial funding. Singh, Epstein, and Glatt had no relevant disclosures.
A version of this article first appeared on Medscape.com.
“We found that screening rates were higher and rose more steeply in pregnant individuals compared to nonpregnant reproductive age females after this guidance.” However overall, HCV screening in women still remained low by the end of 2022, authors Roshni Singh, MD, and Rachel Epstein, MD, MSc, with the section of infectious diseases, Boston Medical Center, noted in an email to this news organization.
The study was published online in JAMA.
The researchers leveraged TriNetX LIVE electronic health record data to compare HCV screening rates from 68 US healthcare organizations covering more than 115 million patients.
Using a multiple-group interrupted time series analysis, they compared HCV screening rates for pregnant and nonpregnant women for each 6-month period before (January 2014 to December 2019) and after (July 2020 to December 2022) the 2020 guidelines. January to June 2020 was considered a washout period to account for the COVID-19 pandemic peak and guideline dissemination.
For the entire 9-year study period (2014-2022), a total of 79,231 incident HCV tests occurred among pregnant women and 678,951 occurred among nonpregnant women.
In the 6 months before the guidance, HCV screening per 1000 person-years increased from 52 to 117 tests among pregnant women and 16 to 24 tests among nonpregnant women.
In the 6 months after the guidance, screening per 1000 person-years increased from 141 to 253 among pregnant women and from 29 to 37 among nonpregnant women.
Yet by the end of 2022, only 38.7% of women with a pregnancy and 8.7% of nonpregnant women were ever tested for the HCV.
How to Boost HCV Screening
These results suggest that “innovative strategies are needed to improve HCV diagnosis and treatment,” the authors wrote.
“Several interventions have been demonstrated to be effective in increasing screening in general, including electronic medical record alerts for opt-out testing, routine test offer by nonclinician office staff, offering testing in nontraditional spaces, including substance use treatment programs, harm reduction centers, STI clinics, and mobile health units,” Singh and Epstein told this news organization.
“A key step is educating primary care providers in addition to addiction medicine and emergency medicine clinicians about the updated guidelines as they interface with a large number of at-risk individuals,” they said. And the most important measure is creating clear work flows that respond to positive results to link people to treatment and cure.
“Clinicians need to feel empowered that their work screening a patient can make a meaningful difference in both the patient’s life and in helping end this epidemic,” the two researchers explained.
Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America, who wasn’t involved in the study, told this news organization that the low HCV screening rates are not surprising.
“We tend not to do well with screening. It’s not necessarily anybody’s fault, but patients don’t necessarily want to be screened. Sometimes physicians are very busy. Sometimes screening is not the most important thing for them to do. Sometimes there are processes in place that fall through,” said Glatt, chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau, Oceanside, New York.
“We tend to do a better job of screening in pregnant than nonpregnant women because pregnancy is a focus and there is 9 months that you can be following-up, so there is more opportunity. A healthy nonpregnant woman may not see her doctor for another year,” Glatt noted.
“I think that many physicians are very good at screening for hepatitis C in patients that are clearly at risk,” he added. “We’re not so good at screening for people” that don’t have a clear risk but do “have risk factors.”
The study had no commercial funding. Singh, Epstein, and Glatt had no relevant disclosures.
A version of this article first appeared on Medscape.com.
SBRT: A New Front-Runner in Treating Localized Renal Cell Carcinoma?
For patients with primary localized renal cell carcinoma (RCC), especially those who aren’t good candidates for surgery, noninvasive or minimally invasive ablative treatments have emerged as important options. These ablative treatments include radiofrequency ablation (RFA), microwave ablation, cryoablation, and the relative new-comer stereotactic body radiotherapy (SBRT).
But how do these approaches stack up against each other?
A recent meta-analysis published in Lancet Oncology found that SBRT appears to be equally safe and potentially more effective than other ablative treatment options for localized RCC.
“Our findings suggest that SBRT might offer a particularly advantageous option for treating larger renal cell carcinoma tumors, yielding the highest local control rates among ablative options with comparatively low rates of severe complications,” Srinivas Raman, MD, Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada, and colleagues wrote.
Outside experts who spoke with Medscape Medical News said SBRT should likely play a larger role in the management of early-stage RCC.
“Given its noninvasive nature, favorable toxicity profile, and comparable renal outcomes, SBRT warrants broader adoption,” said Shankar Siva, PhD, MBBS, a radiation oncologist at the Peter MacCallum Cancer Centre and professor at the University of Melbourne, both in Melbourne, Australia.
This new analysis is “helpful as it provides reassurance and further strong quality data to present in multidisciplinary renal rounds and tumor boards to consider the use of SBRT as an alternative to other ablative technique,” said Joelle Helou, MD, MSc, radiation oncologist, Verspeeten Family Cancer Centre, and assistant professor, Department of Oncology, Western University, both in London, Ontario, Canada.
Filling a Knowledge Gap
RCC is the most common malignancy of the kidney, accounting for > 90% of all renal malignancies. Worldwide, the incidence of RCC has continued to rise, with a 2% annual rate of increase over the past two decades.
The conventional treatment of choice is radical or partial nephrectomy; however, not all patients are ideally suited for surgery, especially those who are older or have compromised kidney function or comorbid conditions.
Ablative therapies have been integrated into clinical guidelines as evidence-based interventions to treat primary RCC. These therapies include RFA and microwave ablation — two minimally invasive thermal ablation techniques that use heat to destroy the tumor tissue — and cryoablation, which uses extreme cold to destroy the tumor tissue.
Studies have generally found similar outcomes with RFA and microwave ablation, with the choice of treatment often guided by what’s available and operator expertise. The US and European guidelines recommend these treatments, particularly for smaller tumors (< 4 cm), citing their effectiveness and minimal invasiveness.
SBRT is a relatively new noninvasive option that delivers highly focused radiation doses to the tumor across multiple sessions and may be particularly suited to larger tumors (≥ 4 cm).
National Comprehensive Cancer Network guidelines state that SBRT may be considered for nonoptimal surgical candidates with stage I, II, or III kidney cancer.
However, comparative data on these four techniques has been limited until now.
What Did the Meta-Analysis Find?
Raman and colleagues performed a systematic review and meta-analysis pooled data from 133 studies involving 8910 patients (mean age, 68 years) with localized RCC treated with one of the four ablative therapies.
Overall, across the four ablative approaches, local control rates were very similar at 1 year, ranging from 95% for cryoablation to 99% for SBRT, and at 2 years, ranging from 94% for cryoablation to 97% for SBRT. At 5 years, however, there was a slightly greater separation in outcomes favoring SBRT (95%) and RFA (92%) compared with cryoablation (90%) and microwave ablation (86%).
Although all four techniques demonstrated similar local control for small tumors measuring < 4 cm, the approaches began to diverge for larger tumors measuring ≥ 4 cm at 1, 2, and 5 years. At 5 years, for instance, SBRT had the highest local control rate (93%), outperforming RFA (79%), microwave ablation (82%), and cryoablation (85%).
Looking at survival outcomes, cancer-specific survival was 100% at 1 year across all treatments. At 5 years, small differences in cancer-specific survival were observed. For smaller tumors, cancer-specific survival ranged from 100% for both SBRT and RFA to 97% for microwave ablation and 98% for cryoablation. For larger tumors, the cancer-specific survival rate was 100% for microwave ablation, 95% for SBRT, and 94% for cryoablation.
These small differences in cancer-specific survival likely reflect differences in patient and tumor characteristics across the treatment groups, the study authors said.
Notably, patients treated with SBRT were older than those treated with microwave ablation and RFA, while also having the largest tumors, which have consistently been shown to be associated with worse local control, greater propensity for regional and distant metastases, worse survival outcomes, and increased treatment-related toxicity, the authors explained.
There were no significant differences in the rate of grade 1-2 adverse events between the ablative methods, although grade 3-4 adverse events occurred in a significantly higher proportion of patients treated with cryoablation (3%) than in those who received RFA and SBRT (2%) or microwave ablation (1%). Baseline or change in renal function, as measured by estimated glomerular filtration rate, did not differ between the ablative techniques.
Overall, the findings reinforce that, although typically offered to older patients with worse baseline renal function and much larger tumors, “SBRT maintained high effectiveness at 1, 2, and 5 years compared to thermal ablation,” Siva told Medscape Medical News.
SBRT in Clinical Practice?
Despite the mounting evidence in favor of SBRT for primary localized RCC unsuitable for surgery, “there is still some reluctance from urologists, mainly, to refer patients for consideration of SBRT,” Helou told Medscape Medical News.
This hesitance is reflected in the meta-analysis, he noted, with SBRT being the least performed ablative therapy (612 patients). Cryoablation was the most common technique used in 3726 patients, followed by RFA (2503 patients) and microwave ablation (2069 patients).
The “compelling efficacy and safety data suggest SBRT should play a larger role in managing early-stage RCC in nonsurgical candidates, particularly for larger tumors where it offers excellent long-term local control,” said Siva, who led the phase 2 FASTTRACK II study evaluating SBRT in patients with inoperable or high-risk primary RCC.
Despite patients having larger than average tumors (4.6 cm) compared with those in many other trials, Siva and colleagues reported a 100% local control rate following SBRT and no patient deaths from cancer during the study period.
The FASTTRACK II study marked “an inflection point for SBRT, and [the approach] is now slowly getting traction,” Chad Tang, MD, radiation oncologist, MD Anderson Cancer Center, Houston, told Medscape Medical News.
Overall, Raman and colleagues said decisions about ablative therapy should be “precisely tailored to the individual patient’s clinical condition and treatment objectives.” Treatment selection should, for instance, depend on tumor size, location, patient comorbidities, availability of a technique, institutional and physician expertise, and patient preference.
Looking ahead, randomized controlled trials across larger patient populations are needed to further elucidate the long-term cancer and survival outcomes associated with these ablative treatments. Research comparing ablative methods with surgery and surveillance as well as exploring other relevant clinical outcomes, such as cost-effectiveness and quality of life, should be performed as well.
“Prospective randomized trials remain essential to further refine the position of SBRT in clinical practice in patients who are surgical candidates,” Siva told Medscape Medical News.
This research had no commercial funding. Raman reported receiving personal fees from AstraZeneca, Sanofi, Knight Pharmaceuticals, Verity Pharma, and Tersera, and grants from Knight Therapeutics, AstraZeneca, and Varian. Siva reported financial relationships with AstraZeneca and Telix Pharmaceuticals. Helou and Tang had no relevant disclosures.
For patients with primary localized renal cell carcinoma (RCC), especially those who aren’t good candidates for surgery, noninvasive or minimally invasive ablative treatments have emerged as important options. These ablative treatments include radiofrequency ablation (RFA), microwave ablation, cryoablation, and the relative new-comer stereotactic body radiotherapy (SBRT).
But how do these approaches stack up against each other?
A recent meta-analysis published in Lancet Oncology found that SBRT appears to be equally safe and potentially more effective than other ablative treatment options for localized RCC.
“Our findings suggest that SBRT might offer a particularly advantageous option for treating larger renal cell carcinoma tumors, yielding the highest local control rates among ablative options with comparatively low rates of severe complications,” Srinivas Raman, MD, Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada, and colleagues wrote.
Outside experts who spoke with Medscape Medical News said SBRT should likely play a larger role in the management of early-stage RCC.
“Given its noninvasive nature, favorable toxicity profile, and comparable renal outcomes, SBRT warrants broader adoption,” said Shankar Siva, PhD, MBBS, a radiation oncologist at the Peter MacCallum Cancer Centre and professor at the University of Melbourne, both in Melbourne, Australia.
This new analysis is “helpful as it provides reassurance and further strong quality data to present in multidisciplinary renal rounds and tumor boards to consider the use of SBRT as an alternative to other ablative technique,” said Joelle Helou, MD, MSc, radiation oncologist, Verspeeten Family Cancer Centre, and assistant professor, Department of Oncology, Western University, both in London, Ontario, Canada.
Filling a Knowledge Gap
RCC is the most common malignancy of the kidney, accounting for > 90% of all renal malignancies. Worldwide, the incidence of RCC has continued to rise, with a 2% annual rate of increase over the past two decades.
The conventional treatment of choice is radical or partial nephrectomy; however, not all patients are ideally suited for surgery, especially those who are older or have compromised kidney function or comorbid conditions.
Ablative therapies have been integrated into clinical guidelines as evidence-based interventions to treat primary RCC. These therapies include RFA and microwave ablation — two minimally invasive thermal ablation techniques that use heat to destroy the tumor tissue — and cryoablation, which uses extreme cold to destroy the tumor tissue.
Studies have generally found similar outcomes with RFA and microwave ablation, with the choice of treatment often guided by what’s available and operator expertise. The US and European guidelines recommend these treatments, particularly for smaller tumors (< 4 cm), citing their effectiveness and minimal invasiveness.
SBRT is a relatively new noninvasive option that delivers highly focused radiation doses to the tumor across multiple sessions and may be particularly suited to larger tumors (≥ 4 cm).
National Comprehensive Cancer Network guidelines state that SBRT may be considered for nonoptimal surgical candidates with stage I, II, or III kidney cancer.
However, comparative data on these four techniques has been limited until now.
What Did the Meta-Analysis Find?
Raman and colleagues performed a systematic review and meta-analysis pooled data from 133 studies involving 8910 patients (mean age, 68 years) with localized RCC treated with one of the four ablative therapies.
Overall, across the four ablative approaches, local control rates were very similar at 1 year, ranging from 95% for cryoablation to 99% for SBRT, and at 2 years, ranging from 94% for cryoablation to 97% for SBRT. At 5 years, however, there was a slightly greater separation in outcomes favoring SBRT (95%) and RFA (92%) compared with cryoablation (90%) and microwave ablation (86%).
Although all four techniques demonstrated similar local control for small tumors measuring < 4 cm, the approaches began to diverge for larger tumors measuring ≥ 4 cm at 1, 2, and 5 years. At 5 years, for instance, SBRT had the highest local control rate (93%), outperforming RFA (79%), microwave ablation (82%), and cryoablation (85%).
Looking at survival outcomes, cancer-specific survival was 100% at 1 year across all treatments. At 5 years, small differences in cancer-specific survival were observed. For smaller tumors, cancer-specific survival ranged from 100% for both SBRT and RFA to 97% for microwave ablation and 98% for cryoablation. For larger tumors, the cancer-specific survival rate was 100% for microwave ablation, 95% for SBRT, and 94% for cryoablation.
These small differences in cancer-specific survival likely reflect differences in patient and tumor characteristics across the treatment groups, the study authors said.
Notably, patients treated with SBRT were older than those treated with microwave ablation and RFA, while also having the largest tumors, which have consistently been shown to be associated with worse local control, greater propensity for regional and distant metastases, worse survival outcomes, and increased treatment-related toxicity, the authors explained.
There were no significant differences in the rate of grade 1-2 adverse events between the ablative methods, although grade 3-4 adverse events occurred in a significantly higher proportion of patients treated with cryoablation (3%) than in those who received RFA and SBRT (2%) or microwave ablation (1%). Baseline or change in renal function, as measured by estimated glomerular filtration rate, did not differ between the ablative techniques.
Overall, the findings reinforce that, although typically offered to older patients with worse baseline renal function and much larger tumors, “SBRT maintained high effectiveness at 1, 2, and 5 years compared to thermal ablation,” Siva told Medscape Medical News.
SBRT in Clinical Practice?
Despite the mounting evidence in favor of SBRT for primary localized RCC unsuitable for surgery, “there is still some reluctance from urologists, mainly, to refer patients for consideration of SBRT,” Helou told Medscape Medical News.
This hesitance is reflected in the meta-analysis, he noted, with SBRT being the least performed ablative therapy (612 patients). Cryoablation was the most common technique used in 3726 patients, followed by RFA (2503 patients) and microwave ablation (2069 patients).
The “compelling efficacy and safety data suggest SBRT should play a larger role in managing early-stage RCC in nonsurgical candidates, particularly for larger tumors where it offers excellent long-term local control,” said Siva, who led the phase 2 FASTTRACK II study evaluating SBRT in patients with inoperable or high-risk primary RCC.
Despite patients having larger than average tumors (4.6 cm) compared with those in many other trials, Siva and colleagues reported a 100% local control rate following SBRT and no patient deaths from cancer during the study period.
The FASTTRACK II study marked “an inflection point for SBRT, and [the approach] is now slowly getting traction,” Chad Tang, MD, radiation oncologist, MD Anderson Cancer Center, Houston, told Medscape Medical News.
Overall, Raman and colleagues said decisions about ablative therapy should be “precisely tailored to the individual patient’s clinical condition and treatment objectives.” Treatment selection should, for instance, depend on tumor size, location, patient comorbidities, availability of a technique, institutional and physician expertise, and patient preference.
Looking ahead, randomized controlled trials across larger patient populations are needed to further elucidate the long-term cancer and survival outcomes associated with these ablative treatments. Research comparing ablative methods with surgery and surveillance as well as exploring other relevant clinical outcomes, such as cost-effectiveness and quality of life, should be performed as well.
“Prospective randomized trials remain essential to further refine the position of SBRT in clinical practice in patients who are surgical candidates,” Siva told Medscape Medical News.
This research had no commercial funding. Raman reported receiving personal fees from AstraZeneca, Sanofi, Knight Pharmaceuticals, Verity Pharma, and Tersera, and grants from Knight Therapeutics, AstraZeneca, and Varian. Siva reported financial relationships with AstraZeneca and Telix Pharmaceuticals. Helou and Tang had no relevant disclosures.
For patients with primary localized renal cell carcinoma (RCC), especially those who aren’t good candidates for surgery, noninvasive or minimally invasive ablative treatments have emerged as important options. These ablative treatments include radiofrequency ablation (RFA), microwave ablation, cryoablation, and the relative new-comer stereotactic body radiotherapy (SBRT).
But how do these approaches stack up against each other?
A recent meta-analysis published in Lancet Oncology found that SBRT appears to be equally safe and potentially more effective than other ablative treatment options for localized RCC.
“Our findings suggest that SBRT might offer a particularly advantageous option for treating larger renal cell carcinoma tumors, yielding the highest local control rates among ablative options with comparatively low rates of severe complications,” Srinivas Raman, MD, Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada, and colleagues wrote.
Outside experts who spoke with Medscape Medical News said SBRT should likely play a larger role in the management of early-stage RCC.
“Given its noninvasive nature, favorable toxicity profile, and comparable renal outcomes, SBRT warrants broader adoption,” said Shankar Siva, PhD, MBBS, a radiation oncologist at the Peter MacCallum Cancer Centre and professor at the University of Melbourne, both in Melbourne, Australia.
This new analysis is “helpful as it provides reassurance and further strong quality data to present in multidisciplinary renal rounds and tumor boards to consider the use of SBRT as an alternative to other ablative technique,” said Joelle Helou, MD, MSc, radiation oncologist, Verspeeten Family Cancer Centre, and assistant professor, Department of Oncology, Western University, both in London, Ontario, Canada.
Filling a Knowledge Gap
RCC is the most common malignancy of the kidney, accounting for > 90% of all renal malignancies. Worldwide, the incidence of RCC has continued to rise, with a 2% annual rate of increase over the past two decades.
The conventional treatment of choice is radical or partial nephrectomy; however, not all patients are ideally suited for surgery, especially those who are older or have compromised kidney function or comorbid conditions.
Ablative therapies have been integrated into clinical guidelines as evidence-based interventions to treat primary RCC. These therapies include RFA and microwave ablation — two minimally invasive thermal ablation techniques that use heat to destroy the tumor tissue — and cryoablation, which uses extreme cold to destroy the tumor tissue.
Studies have generally found similar outcomes with RFA and microwave ablation, with the choice of treatment often guided by what’s available and operator expertise. The US and European guidelines recommend these treatments, particularly for smaller tumors (< 4 cm), citing their effectiveness and minimal invasiveness.
SBRT is a relatively new noninvasive option that delivers highly focused radiation doses to the tumor across multiple sessions and may be particularly suited to larger tumors (≥ 4 cm).
National Comprehensive Cancer Network guidelines state that SBRT may be considered for nonoptimal surgical candidates with stage I, II, or III kidney cancer.
However, comparative data on these four techniques has been limited until now.
What Did the Meta-Analysis Find?
Raman and colleagues performed a systematic review and meta-analysis pooled data from 133 studies involving 8910 patients (mean age, 68 years) with localized RCC treated with one of the four ablative therapies.
Overall, across the four ablative approaches, local control rates were very similar at 1 year, ranging from 95% for cryoablation to 99% for SBRT, and at 2 years, ranging from 94% for cryoablation to 97% for SBRT. At 5 years, however, there was a slightly greater separation in outcomes favoring SBRT (95%) and RFA (92%) compared with cryoablation (90%) and microwave ablation (86%).
Although all four techniques demonstrated similar local control for small tumors measuring < 4 cm, the approaches began to diverge for larger tumors measuring ≥ 4 cm at 1, 2, and 5 years. At 5 years, for instance, SBRT had the highest local control rate (93%), outperforming RFA (79%), microwave ablation (82%), and cryoablation (85%).
Looking at survival outcomes, cancer-specific survival was 100% at 1 year across all treatments. At 5 years, small differences in cancer-specific survival were observed. For smaller tumors, cancer-specific survival ranged from 100% for both SBRT and RFA to 97% for microwave ablation and 98% for cryoablation. For larger tumors, the cancer-specific survival rate was 100% for microwave ablation, 95% for SBRT, and 94% for cryoablation.
These small differences in cancer-specific survival likely reflect differences in patient and tumor characteristics across the treatment groups, the study authors said.
Notably, patients treated with SBRT were older than those treated with microwave ablation and RFA, while also having the largest tumors, which have consistently been shown to be associated with worse local control, greater propensity for regional and distant metastases, worse survival outcomes, and increased treatment-related toxicity, the authors explained.
There were no significant differences in the rate of grade 1-2 adverse events between the ablative methods, although grade 3-4 adverse events occurred in a significantly higher proportion of patients treated with cryoablation (3%) than in those who received RFA and SBRT (2%) or microwave ablation (1%). Baseline or change in renal function, as measured by estimated glomerular filtration rate, did not differ between the ablative techniques.
Overall, the findings reinforce that, although typically offered to older patients with worse baseline renal function and much larger tumors, “SBRT maintained high effectiveness at 1, 2, and 5 years compared to thermal ablation,” Siva told Medscape Medical News.
SBRT in Clinical Practice?
Despite the mounting evidence in favor of SBRT for primary localized RCC unsuitable for surgery, “there is still some reluctance from urologists, mainly, to refer patients for consideration of SBRT,” Helou told Medscape Medical News.
This hesitance is reflected in the meta-analysis, he noted, with SBRT being the least performed ablative therapy (612 patients). Cryoablation was the most common technique used in 3726 patients, followed by RFA (2503 patients) and microwave ablation (2069 patients).
The “compelling efficacy and safety data suggest SBRT should play a larger role in managing early-stage RCC in nonsurgical candidates, particularly for larger tumors where it offers excellent long-term local control,” said Siva, who led the phase 2 FASTTRACK II study evaluating SBRT in patients with inoperable or high-risk primary RCC.
Despite patients having larger than average tumors (4.6 cm) compared with those in many other trials, Siva and colleagues reported a 100% local control rate following SBRT and no patient deaths from cancer during the study period.
The FASTTRACK II study marked “an inflection point for SBRT, and [the approach] is now slowly getting traction,” Chad Tang, MD, radiation oncologist, MD Anderson Cancer Center, Houston, told Medscape Medical News.
Overall, Raman and colleagues said decisions about ablative therapy should be “precisely tailored to the individual patient’s clinical condition and treatment objectives.” Treatment selection should, for instance, depend on tumor size, location, patient comorbidities, availability of a technique, institutional and physician expertise, and patient preference.
Looking ahead, randomized controlled trials across larger patient populations are needed to further elucidate the long-term cancer and survival outcomes associated with these ablative treatments. Research comparing ablative methods with surgery and surveillance as well as exploring other relevant clinical outcomes, such as cost-effectiveness and quality of life, should be performed as well.
“Prospective randomized trials remain essential to further refine the position of SBRT in clinical practice in patients who are surgical candidates,” Siva told Medscape Medical News.
This research had no commercial funding. Raman reported receiving personal fees from AstraZeneca, Sanofi, Knight Pharmaceuticals, Verity Pharma, and Tersera, and grants from Knight Therapeutics, AstraZeneca, and Varian. Siva reported financial relationships with AstraZeneca and Telix Pharmaceuticals. Helou and Tang had no relevant disclosures.
Diet Changes Show Promise in Early Prostate Cancer
A diet high in omega-3 and low in omega-6 fatty acids, alongside fish oil supplements, may curb the growth of prostate cancer cells in men with early-stage disease, new data showed.
Among men on active surveillance for prostate cancer, consuming this diet for a year led to a significant decrease in the prostate cancer tissue Ki-67 index, a biomarker for prostate cancer progression, metastasis, and death, according to findings from the phase 2 CAPFISH-3 study presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium.
“This data is certainly intriguing and supports studies looking at this further in prostate cancer,” Bradley Alexander McGregor, MD, from Dana-Farber Cancer Institute, Boston, Massachusetts, who wasn’t involved in the study, told this news organization. But, McGregor noted, patients were on the diet for 1 year, and the long-term implications of this diet are not known.
Growing Evidence on Diet
Diets that include fried and processed foods tend to be high in omega 6s, while those that include salmon and tuna are higher in omega 3s.
Research has shown that consuming more omega-3 fatty acids is associated with a lower risk for mortality from prostate cancer, explained study investigator William Aronson, MD, with David Geffen School of Medicine at University of California, Los Angeles (UCLA). Research suggests that ingesting more omega-6 accelerates the growth of human tumors in mice, while raising omega-3 levels lowers it. High omega-3 and low omega-6 are also known to have an inhibitory effect on M2-like macrophages, which are the predominant immune cell type in prostate cancer metastasis.
To investigate the impact of these fatty acids on early-stage prostate cancer, Aronson and colleagues conducted a single-center, phase 2, randomized, open-label study in 100 men with grade 1/2 prostate cancer who elected active surveillance.
Patients were randomly allocated 1:1 to a control group that continued their normal diet (minus fish oil) or to an intervention group that followed a low omega-6/high omega-3 diet, supplemented with fish oil (2.2 g/d), for 1 year.
The primary endpoint was the change in Ki-67 index from baseline to 1 year from same-site biopsies between the groups.
For the primary endpoint, the Ki-67 index decreased in the intervention group by 15% from baseline to 1 year and increased in the control group by 24%. The difference between groups was statistically significant (P = .043).
For the secondary endpoints, the intervention led to a reduction in triglyceride levels and macrophage colony stimulating factor but no change in tumor volume grade group, PSA level, or Decipher 22 gene score.
Aronson said the findings support future phase 3 trials incorporating this intervention among men on active surveillance for prostate cancer.
McGregor said it’s important to note that this was “an aggressive intervention with dietary changes and addition of fish oil and patients need to be highly motivated.” Four men discontinued due to adverse effects — primarily gastrointestinal adverse effects such as diarrhea and nausea — larger sample sizes will be key to better understand the tolerability.
Bottom line, said McGregor, “based on this data alone, it should not be recommended but can be considered for highly motivated patients after discussion of the limitations of available data and side effects.”
The study was funded in part by the National Cancer Institute, the UCLA Health Jonsson Comprehensive Cancer Center, Howard B. Klein, and the Seafood Industry Research Fund. Aronson disclosed relationships with AstraZeneca, Bayer, Blue Earth Diagnostics, Janssen Oncology, and Pfizer/Astellas. McGregor disclosed relationships with Arcus Biosciences, Astellas Pharma, Bristol Myers Squibb, Daiichi Sankyo/AstraZeneca, Eisai, Exelixis, Genmab, Gilead Sciences, Loxo/Lilly, Pfizer, and Seattle Genetics/Astellas.
A version of this article first appeared on Medscape.com.
A diet high in omega-3 and low in omega-6 fatty acids, alongside fish oil supplements, may curb the growth of prostate cancer cells in men with early-stage disease, new data showed.
Among men on active surveillance for prostate cancer, consuming this diet for a year led to a significant decrease in the prostate cancer tissue Ki-67 index, a biomarker for prostate cancer progression, metastasis, and death, according to findings from the phase 2 CAPFISH-3 study presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium.
“This data is certainly intriguing and supports studies looking at this further in prostate cancer,” Bradley Alexander McGregor, MD, from Dana-Farber Cancer Institute, Boston, Massachusetts, who wasn’t involved in the study, told this news organization. But, McGregor noted, patients were on the diet for 1 year, and the long-term implications of this diet are not known.
Growing Evidence on Diet
Diets that include fried and processed foods tend to be high in omega 6s, while those that include salmon and tuna are higher in omega 3s.
Research has shown that consuming more omega-3 fatty acids is associated with a lower risk for mortality from prostate cancer, explained study investigator William Aronson, MD, with David Geffen School of Medicine at University of California, Los Angeles (UCLA). Research suggests that ingesting more omega-6 accelerates the growth of human tumors in mice, while raising omega-3 levels lowers it. High omega-3 and low omega-6 are also known to have an inhibitory effect on M2-like macrophages, which are the predominant immune cell type in prostate cancer metastasis.
To investigate the impact of these fatty acids on early-stage prostate cancer, Aronson and colleagues conducted a single-center, phase 2, randomized, open-label study in 100 men with grade 1/2 prostate cancer who elected active surveillance.
Patients were randomly allocated 1:1 to a control group that continued their normal diet (minus fish oil) or to an intervention group that followed a low omega-6/high omega-3 diet, supplemented with fish oil (2.2 g/d), for 1 year.
The primary endpoint was the change in Ki-67 index from baseline to 1 year from same-site biopsies between the groups.
For the primary endpoint, the Ki-67 index decreased in the intervention group by 15% from baseline to 1 year and increased in the control group by 24%. The difference between groups was statistically significant (P = .043).
For the secondary endpoints, the intervention led to a reduction in triglyceride levels and macrophage colony stimulating factor but no change in tumor volume grade group, PSA level, or Decipher 22 gene score.
Aronson said the findings support future phase 3 trials incorporating this intervention among men on active surveillance for prostate cancer.
McGregor said it’s important to note that this was “an aggressive intervention with dietary changes and addition of fish oil and patients need to be highly motivated.” Four men discontinued due to adverse effects — primarily gastrointestinal adverse effects such as diarrhea and nausea — larger sample sizes will be key to better understand the tolerability.
Bottom line, said McGregor, “based on this data alone, it should not be recommended but can be considered for highly motivated patients after discussion of the limitations of available data and side effects.”
The study was funded in part by the National Cancer Institute, the UCLA Health Jonsson Comprehensive Cancer Center, Howard B. Klein, and the Seafood Industry Research Fund. Aronson disclosed relationships with AstraZeneca, Bayer, Blue Earth Diagnostics, Janssen Oncology, and Pfizer/Astellas. McGregor disclosed relationships with Arcus Biosciences, Astellas Pharma, Bristol Myers Squibb, Daiichi Sankyo/AstraZeneca, Eisai, Exelixis, Genmab, Gilead Sciences, Loxo/Lilly, Pfizer, and Seattle Genetics/Astellas.
A version of this article first appeared on Medscape.com.
A diet high in omega-3 and low in omega-6 fatty acids, alongside fish oil supplements, may curb the growth of prostate cancer cells in men with early-stage disease, new data showed.
Among men on active surveillance for prostate cancer, consuming this diet for a year led to a significant decrease in the prostate cancer tissue Ki-67 index, a biomarker for prostate cancer progression, metastasis, and death, according to findings from the phase 2 CAPFISH-3 study presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium.
“This data is certainly intriguing and supports studies looking at this further in prostate cancer,” Bradley Alexander McGregor, MD, from Dana-Farber Cancer Institute, Boston, Massachusetts, who wasn’t involved in the study, told this news organization. But, McGregor noted, patients were on the diet for 1 year, and the long-term implications of this diet are not known.
Growing Evidence on Diet
Diets that include fried and processed foods tend to be high in omega 6s, while those that include salmon and tuna are higher in omega 3s.
Research has shown that consuming more omega-3 fatty acids is associated with a lower risk for mortality from prostate cancer, explained study investigator William Aronson, MD, with David Geffen School of Medicine at University of California, Los Angeles (UCLA). Research suggests that ingesting more omega-6 accelerates the growth of human tumors in mice, while raising omega-3 levels lowers it. High omega-3 and low omega-6 are also known to have an inhibitory effect on M2-like macrophages, which are the predominant immune cell type in prostate cancer metastasis.
To investigate the impact of these fatty acids on early-stage prostate cancer, Aronson and colleagues conducted a single-center, phase 2, randomized, open-label study in 100 men with grade 1/2 prostate cancer who elected active surveillance.
Patients were randomly allocated 1:1 to a control group that continued their normal diet (minus fish oil) or to an intervention group that followed a low omega-6/high omega-3 diet, supplemented with fish oil (2.2 g/d), for 1 year.
The primary endpoint was the change in Ki-67 index from baseline to 1 year from same-site biopsies between the groups.
For the primary endpoint, the Ki-67 index decreased in the intervention group by 15% from baseline to 1 year and increased in the control group by 24%. The difference between groups was statistically significant (P = .043).
For the secondary endpoints, the intervention led to a reduction in triglyceride levels and macrophage colony stimulating factor but no change in tumor volume grade group, PSA level, or Decipher 22 gene score.
Aronson said the findings support future phase 3 trials incorporating this intervention among men on active surveillance for prostate cancer.
McGregor said it’s important to note that this was “an aggressive intervention with dietary changes and addition of fish oil and patients need to be highly motivated.” Four men discontinued due to adverse effects — primarily gastrointestinal adverse effects such as diarrhea and nausea — larger sample sizes will be key to better understand the tolerability.
Bottom line, said McGregor, “based on this data alone, it should not be recommended but can be considered for highly motivated patients after discussion of the limitations of available data and side effects.”
The study was funded in part by the National Cancer Institute, the UCLA Health Jonsson Comprehensive Cancer Center, Howard B. Klein, and the Seafood Industry Research Fund. Aronson disclosed relationships with AstraZeneca, Bayer, Blue Earth Diagnostics, Janssen Oncology, and Pfizer/Astellas. McGregor disclosed relationships with Arcus Biosciences, Astellas Pharma, Bristol Myers Squibb, Daiichi Sankyo/AstraZeneca, Eisai, Exelixis, Genmab, Gilead Sciences, Loxo/Lilly, Pfizer, and Seattle Genetics/Astellas.
A version of this article first appeared on Medscape.com.
FROM GUCS 2025
Navigating Esophageal Dysfunction in Immune and Infectious Disorders: AGA Clinical Practice Update
“Many different disorders can lead to esophageal dysfunction, which is characterized by symptoms including dysphagia, odynophagia, chest pain and heartburn. These symptoms can be caused either by immune or infectious conditions and can either be localized to the esophagus or part of a larger systemic process,” co–first author Emily McGowan, MD, PhD, with the division of allergy and immunology, University of Virginia School of Medicine, Charlottesville, said in an AGA podcast.
However, without a “high index of suspicion,” these conditions can be overlooked, leading to delays in diagnosis and unnecessary procedures. “With this clinical practice update, we wanted to help providers more readily recognize these conditions so that patients can be diagnosed and treated earlier in the course of their disease,” McGowan explained.
“This is a fantastic review that highlights how many different systemic disorders can affect the esophagus,” Scott Gabbard, MD, gastroenterologist and section head at the Center for Neurogastroenterology and Motility, Cleveland Clinic, Ohio, who wasn’t involved in the review, said in an interview.
“Honestly, for the practicing gastroenterologist, this is one of those reviews that I could envision someone either saving to his or her desktop for reference or printing it and pinning it next to his or her desk,” Gabbard said.
Best Practice Advice
The clinical practice update is published in Clinical Gastroenterology and Hepatology. It includes 10 “best practice advice” statements and a table highlighting “important” considerations when evaluating patients with esophageal dysfunction.
The review authors note that esophageal dysfunction may result from localized infections — most commonly Candida, herpes simplex virus, and cytomegalovirus — or systemic immune-mediated diseases, such as systemic sclerosis (SSc), mixed connective tissue disease (MCTD), and eosinophilic esophagitis (EoE).
They advise clinicians to identify if there are risks for inflammatory or infectious possibilities for a patient’s esophageal symptoms and investigate for these disorders as a potential cause of esophageal dysfunction.
Once esophageal infection is identified, it’s important to identify whether accompanying signs and symptoms point to immunocompromise leading to a more systemic infection. Consultation with an infectious disease expert is recommended to guide appropriate treatment, the authors said.
If symptoms fail to improve after therapy for infectious esophagitis, the patient should be evaluated for refractory infection or additional underlying sources of esophageal and immunologic dysfunction is advised.
It’s also important to recognize that patients with EoE who continue to have symptoms of esophageal dysfunction despite histologic and endoscopic disease remission, may develop a motility disorder and evaluation of esophageal motility may be warranted, the authors said.
In patients with histologic and endoscopic features of lymphocytic esophagitis, treatment of lymphocytic-related inflammation with proton-pump inhibitor (PPI) therapy or swallowed topical corticosteroids and esophageal dilation as needed should be considered.
In patients who present with esophageal symptoms in the setting of hypereosinophilia (absolute eosinophil count > 1500 cells/uL), the authors advise further workup of non-EoE eosinophilic gastrointestinal disease, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis should be considered, with consultation with an allergy/immunology specialist if helpful.
In patients with rheumatologic diseases, especially SSc and MCTD, it’s important to be aware that esophageal symptoms can occur because of involvement of the esophageal muscle layer, resulting in dysmotility and/or incompetence of the lower esophageal sphincter, they said.
In the setting of Crohn’s disease, some patients can develop esophageal involvement from inflammation, stricturing, or fistulizing changes with granulomas seen histologically. Esophageal manifestations of Crohn’s disease tend to occur in patients with active intestinal disease.
In patients with dermatologic diseases of lichen planus or bullous disorders, dysphagia can occur because of endoscopically visible esophageal mucosal involvement. Esophageal lichen planus, in particular, can occur without skin involvement and can be difficult to define on esophageal histopathology.
The authors also advise clinicians to consider infectious and inflammatory causes of secondary achalasia during initial evaluation.
“Achalasia and EoE might coexist more commonly than what gastroenterologists think, especially in younger patients,” co–first author Chanakyaram Reddy, MD, a gastroenterologist with Baylor University Medical Center, Dallas, Texas, said in the AGA podcast.
He noted that in a recent population-based study, the estimated relative risk of EoE was over 30-fold higher in patients with achalasia aged ≤ 40 years.
“In any suspected achalasia case, it would be wise to obtain biopsies throughout the entire esophagus when the patient is off confounding medications such as PPI therapy to establish if significant esophageal eosinophilia is coexistent,” Reddy said.
“If EoE-level eosinophilia is found, it would be reasonable to consider treating medically for EoE prior to committing to achalasia-specific interventions, which often involve permanent disruption of the esophageal muscle layer,” he added.
Gabbard said this review helps the clinician think beyond gastroesophageal reflux disease (GERD) — the most common cause of esophageal dysfunction — and consider other causes for esophageal dysfunction.
“We are seeing more complex disorders affect the esophagus. It’s not just GERD and you absolutely need a high index of suspicion because you can find varying disorders to blame for many esophageal symptoms that could otherwise be thought to be just reflux,” he said.
This research had no commercial funding. Disclosures for the authors are listed with the original article. Gabbard had no relevant disclosures.
A version of this article appeared on Medscape.com.
“Many different disorders can lead to esophageal dysfunction, which is characterized by symptoms including dysphagia, odynophagia, chest pain and heartburn. These symptoms can be caused either by immune or infectious conditions and can either be localized to the esophagus or part of a larger systemic process,” co–first author Emily McGowan, MD, PhD, with the division of allergy and immunology, University of Virginia School of Medicine, Charlottesville, said in an AGA podcast.
However, without a “high index of suspicion,” these conditions can be overlooked, leading to delays in diagnosis and unnecessary procedures. “With this clinical practice update, we wanted to help providers more readily recognize these conditions so that patients can be diagnosed and treated earlier in the course of their disease,” McGowan explained.
“This is a fantastic review that highlights how many different systemic disorders can affect the esophagus,” Scott Gabbard, MD, gastroenterologist and section head at the Center for Neurogastroenterology and Motility, Cleveland Clinic, Ohio, who wasn’t involved in the review, said in an interview.
“Honestly, for the practicing gastroenterologist, this is one of those reviews that I could envision someone either saving to his or her desktop for reference or printing it and pinning it next to his or her desk,” Gabbard said.
Best Practice Advice
The clinical practice update is published in Clinical Gastroenterology and Hepatology. It includes 10 “best practice advice” statements and a table highlighting “important” considerations when evaluating patients with esophageal dysfunction.
The review authors note that esophageal dysfunction may result from localized infections — most commonly Candida, herpes simplex virus, and cytomegalovirus — or systemic immune-mediated diseases, such as systemic sclerosis (SSc), mixed connective tissue disease (MCTD), and eosinophilic esophagitis (EoE).
They advise clinicians to identify if there are risks for inflammatory or infectious possibilities for a patient’s esophageal symptoms and investigate for these disorders as a potential cause of esophageal dysfunction.
Once esophageal infection is identified, it’s important to identify whether accompanying signs and symptoms point to immunocompromise leading to a more systemic infection. Consultation with an infectious disease expert is recommended to guide appropriate treatment, the authors said.
If symptoms fail to improve after therapy for infectious esophagitis, the patient should be evaluated for refractory infection or additional underlying sources of esophageal and immunologic dysfunction is advised.
It’s also important to recognize that patients with EoE who continue to have symptoms of esophageal dysfunction despite histologic and endoscopic disease remission, may develop a motility disorder and evaluation of esophageal motility may be warranted, the authors said.
In patients with histologic and endoscopic features of lymphocytic esophagitis, treatment of lymphocytic-related inflammation with proton-pump inhibitor (PPI) therapy or swallowed topical corticosteroids and esophageal dilation as needed should be considered.
In patients who present with esophageal symptoms in the setting of hypereosinophilia (absolute eosinophil count > 1500 cells/uL), the authors advise further workup of non-EoE eosinophilic gastrointestinal disease, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis should be considered, with consultation with an allergy/immunology specialist if helpful.
In patients with rheumatologic diseases, especially SSc and MCTD, it’s important to be aware that esophageal symptoms can occur because of involvement of the esophageal muscle layer, resulting in dysmotility and/or incompetence of the lower esophageal sphincter, they said.
In the setting of Crohn’s disease, some patients can develop esophageal involvement from inflammation, stricturing, or fistulizing changes with granulomas seen histologically. Esophageal manifestations of Crohn’s disease tend to occur in patients with active intestinal disease.
In patients with dermatologic diseases of lichen planus or bullous disorders, dysphagia can occur because of endoscopically visible esophageal mucosal involvement. Esophageal lichen planus, in particular, can occur without skin involvement and can be difficult to define on esophageal histopathology.
The authors also advise clinicians to consider infectious and inflammatory causes of secondary achalasia during initial evaluation.
“Achalasia and EoE might coexist more commonly than what gastroenterologists think, especially in younger patients,” co–first author Chanakyaram Reddy, MD, a gastroenterologist with Baylor University Medical Center, Dallas, Texas, said in the AGA podcast.
He noted that in a recent population-based study, the estimated relative risk of EoE was over 30-fold higher in patients with achalasia aged ≤ 40 years.
“In any suspected achalasia case, it would be wise to obtain biopsies throughout the entire esophagus when the patient is off confounding medications such as PPI therapy to establish if significant esophageal eosinophilia is coexistent,” Reddy said.
“If EoE-level eosinophilia is found, it would be reasonable to consider treating medically for EoE prior to committing to achalasia-specific interventions, which often involve permanent disruption of the esophageal muscle layer,” he added.
Gabbard said this review helps the clinician think beyond gastroesophageal reflux disease (GERD) — the most common cause of esophageal dysfunction — and consider other causes for esophageal dysfunction.
“We are seeing more complex disorders affect the esophagus. It’s not just GERD and you absolutely need a high index of suspicion because you can find varying disorders to blame for many esophageal symptoms that could otherwise be thought to be just reflux,” he said.
This research had no commercial funding. Disclosures for the authors are listed with the original article. Gabbard had no relevant disclosures.
A version of this article appeared on Medscape.com.
“Many different disorders can lead to esophageal dysfunction, which is characterized by symptoms including dysphagia, odynophagia, chest pain and heartburn. These symptoms can be caused either by immune or infectious conditions and can either be localized to the esophagus or part of a larger systemic process,” co–first author Emily McGowan, MD, PhD, with the division of allergy and immunology, University of Virginia School of Medicine, Charlottesville, said in an AGA podcast.
However, without a “high index of suspicion,” these conditions can be overlooked, leading to delays in diagnosis and unnecessary procedures. “With this clinical practice update, we wanted to help providers more readily recognize these conditions so that patients can be diagnosed and treated earlier in the course of their disease,” McGowan explained.
“This is a fantastic review that highlights how many different systemic disorders can affect the esophagus,” Scott Gabbard, MD, gastroenterologist and section head at the Center for Neurogastroenterology and Motility, Cleveland Clinic, Ohio, who wasn’t involved in the review, said in an interview.
“Honestly, for the practicing gastroenterologist, this is one of those reviews that I could envision someone either saving to his or her desktop for reference or printing it and pinning it next to his or her desk,” Gabbard said.
Best Practice Advice
The clinical practice update is published in Clinical Gastroenterology and Hepatology. It includes 10 “best practice advice” statements and a table highlighting “important” considerations when evaluating patients with esophageal dysfunction.
The review authors note that esophageal dysfunction may result from localized infections — most commonly Candida, herpes simplex virus, and cytomegalovirus — or systemic immune-mediated diseases, such as systemic sclerosis (SSc), mixed connective tissue disease (MCTD), and eosinophilic esophagitis (EoE).
They advise clinicians to identify if there are risks for inflammatory or infectious possibilities for a patient’s esophageal symptoms and investigate for these disorders as a potential cause of esophageal dysfunction.
Once esophageal infection is identified, it’s important to identify whether accompanying signs and symptoms point to immunocompromise leading to a more systemic infection. Consultation with an infectious disease expert is recommended to guide appropriate treatment, the authors said.
If symptoms fail to improve after therapy for infectious esophagitis, the patient should be evaluated for refractory infection or additional underlying sources of esophageal and immunologic dysfunction is advised.
It’s also important to recognize that patients with EoE who continue to have symptoms of esophageal dysfunction despite histologic and endoscopic disease remission, may develop a motility disorder and evaluation of esophageal motility may be warranted, the authors said.
In patients with histologic and endoscopic features of lymphocytic esophagitis, treatment of lymphocytic-related inflammation with proton-pump inhibitor (PPI) therapy or swallowed topical corticosteroids and esophageal dilation as needed should be considered.
In patients who present with esophageal symptoms in the setting of hypereosinophilia (absolute eosinophil count > 1500 cells/uL), the authors advise further workup of non-EoE eosinophilic gastrointestinal disease, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis should be considered, with consultation with an allergy/immunology specialist if helpful.
In patients with rheumatologic diseases, especially SSc and MCTD, it’s important to be aware that esophageal symptoms can occur because of involvement of the esophageal muscle layer, resulting in dysmotility and/or incompetence of the lower esophageal sphincter, they said.
In the setting of Crohn’s disease, some patients can develop esophageal involvement from inflammation, stricturing, or fistulizing changes with granulomas seen histologically. Esophageal manifestations of Crohn’s disease tend to occur in patients with active intestinal disease.
In patients with dermatologic diseases of lichen planus or bullous disorders, dysphagia can occur because of endoscopically visible esophageal mucosal involvement. Esophageal lichen planus, in particular, can occur without skin involvement and can be difficult to define on esophageal histopathology.
The authors also advise clinicians to consider infectious and inflammatory causes of secondary achalasia during initial evaluation.
“Achalasia and EoE might coexist more commonly than what gastroenterologists think, especially in younger patients,” co–first author Chanakyaram Reddy, MD, a gastroenterologist with Baylor University Medical Center, Dallas, Texas, said in the AGA podcast.
He noted that in a recent population-based study, the estimated relative risk of EoE was over 30-fold higher in patients with achalasia aged ≤ 40 years.
“In any suspected achalasia case, it would be wise to obtain biopsies throughout the entire esophagus when the patient is off confounding medications such as PPI therapy to establish if significant esophageal eosinophilia is coexistent,” Reddy said.
“If EoE-level eosinophilia is found, it would be reasonable to consider treating medically for EoE prior to committing to achalasia-specific interventions, which often involve permanent disruption of the esophageal muscle layer,” he added.
Gabbard said this review helps the clinician think beyond gastroesophageal reflux disease (GERD) — the most common cause of esophageal dysfunction — and consider other causes for esophageal dysfunction.
“We are seeing more complex disorders affect the esophagus. It’s not just GERD and you absolutely need a high index of suspicion because you can find varying disorders to blame for many esophageal symptoms that could otherwise be thought to be just reflux,” he said.
This research had no commercial funding. Disclosures for the authors are listed with the original article. Gabbard had no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Best Practices When Using POEM to Treat Achalasia: AGA Clinical Update
The American Gastroenterological Association (AGA) has released
“Any patient suspected to have achalasia, or difficulty swallowing for that matter, should undergo a comprehensive diagnostic workup, and that should include clinical history, review of medication, as well as tests. The diagnosis should not be based on isolated tests but on the clinical picture as a whole,” first author Dennis Yang, MD, AGAF, with the Center for Interventional Endoscopy, AdventHealth, Orlando, Florida, noted in an AGA podcast about the update.
The clinical practice update, published in Gastroenterology, includes 12 “best practice advice” statements.
Since its introduction to clinical practice more than a decade ago, POEM has matured and gained widespread acceptance because of its efficacy and safety profile.
POEM has at least similar outcomes to laparoscopic Heller myotomy and pneumatic dilation for type I and type II achalasia with better results for those with type III achalasia, Yang noted.
“However, besides disease phenotype, we need to remember that choosing the right treatment for the patient is going to be based on multiple factors including patient characteristics as well as local expertise,” Yang added.
In terms of technical considerations, the update states that both anterior and posterior tunnel approaches demonstrate comparable success and postprocedure reflux rates. Tunnel orientation should be tailored to the patient’s surgical history and endoscopist’s preference.
It further states that optimal length of the myotomy in the esophagus and cardia, as it pertains to treatment efficacy and risk for postprocedure reflux, remains to be determined.
Adjunct techniques, including real-time intraprocedure functional luminal impedance planimetry, may be considered to tailor or confirm the adequacy of the myotomy.
Same-day discharge after POEM can be considered in select patients who meet discharge criteria. Patients with advanced age, significant comorbidities, poor social support, and/or access to specialized care should be considered for hospital admission, irrespective of symptoms.
The update notes that specific guidelines on the role and extent of antibiotic prophylaxis before and after POEM are lacking. A single dose of antibiotics at the time of POEM “may be sufficient” for antibiotic prophylaxis.
In terms of immediate post-POEM care, the update notes that the clinical impact of routine esophagram or endoscopy immediately post-POEM remains unclear. Testing can be considered based on local practice preferences and in cases in which intraprocedural events or postprocedural findings warrant further evaluation.
Proton pump inhibitors are recommended immediately following POEM, as gastroesophageal reflux disease (GERD) is common following POEM, occurring in up to 65% of cases.
Routine endoscopic surveillance is advised to monitor GERD, disease progression, and esophageal cancer risk, which is significantly higher in achalasia patients.
“Just like diabetes and hypertension, we need to remember that achalasia is a chronic disease and long-term postprocedural surveillance is strongly encouraged to monitor disease progression as well as potential complications of reflux,” Yang said.
He noted that surveillance should be considered irrespective of patient symptoms because many of these patients may remain asymptomatic.
“Primary gastroenterologists should have a very low threshold in referring the patient back to the POEM endoscopist or any specialized esophageal center because the ideology of symptoms in these patients can be quite difficult to tease out and often require comprehensive diagnostic workup,” Yang said.
Evidence for POEM in esophagogastric outflow obstruction and other nonachalasia spastic motility disorders is limited and should only be considered on a case-by-case basis after other less invasive approaches have been exhausted, the update states.
For perspective on the POEM clinical practice update, this news organization spoke with Mouen Khashab, MD, director of therapeutic endoscopy, Johns Hopkins University, Baltimore, Maryland.
“The document is very well written and comprehensive,” Khashab said.
However, Khashab said he would have liked to see greater emphasis on the value or role of a short myotomy in the esophagus and cardia.
“There is level I evidence that the short esophageal myotomy is equivalent to a long esophageal myotomy for type I and II achalasia. When you do a short myotomy, you save procedure time and there is potentially a lower incidence of blown-out myotomy or BOM,” Khashab said.
Khashab also noted that a long myotomy on the gastric side “likely increases the risk of reflux disease, and therefore a limited myotomy on the gastric side likely also is advantageous.”
This research had no commercial funding. Yang serves as a consultant for Boston Scientific, Olympus, FujiFilm, Microtech, Medtronic, 3D-Matrix, and Neptune Medical, and has received research support from Microtech and 3D-Matrix. Khashab had no relevant disclosures.
A version of this article appeared on Medscape.com .
The American Gastroenterological Association (AGA) has released
“Any patient suspected to have achalasia, or difficulty swallowing for that matter, should undergo a comprehensive diagnostic workup, and that should include clinical history, review of medication, as well as tests. The diagnosis should not be based on isolated tests but on the clinical picture as a whole,” first author Dennis Yang, MD, AGAF, with the Center for Interventional Endoscopy, AdventHealth, Orlando, Florida, noted in an AGA podcast about the update.
The clinical practice update, published in Gastroenterology, includes 12 “best practice advice” statements.
Since its introduction to clinical practice more than a decade ago, POEM has matured and gained widespread acceptance because of its efficacy and safety profile.
POEM has at least similar outcomes to laparoscopic Heller myotomy and pneumatic dilation for type I and type II achalasia with better results for those with type III achalasia, Yang noted.
“However, besides disease phenotype, we need to remember that choosing the right treatment for the patient is going to be based on multiple factors including patient characteristics as well as local expertise,” Yang added.
In terms of technical considerations, the update states that both anterior and posterior tunnel approaches demonstrate comparable success and postprocedure reflux rates. Tunnel orientation should be tailored to the patient’s surgical history and endoscopist’s preference.
It further states that optimal length of the myotomy in the esophagus and cardia, as it pertains to treatment efficacy and risk for postprocedure reflux, remains to be determined.
Adjunct techniques, including real-time intraprocedure functional luminal impedance planimetry, may be considered to tailor or confirm the adequacy of the myotomy.
Same-day discharge after POEM can be considered in select patients who meet discharge criteria. Patients with advanced age, significant comorbidities, poor social support, and/or access to specialized care should be considered for hospital admission, irrespective of symptoms.
The update notes that specific guidelines on the role and extent of antibiotic prophylaxis before and after POEM are lacking. A single dose of antibiotics at the time of POEM “may be sufficient” for antibiotic prophylaxis.
In terms of immediate post-POEM care, the update notes that the clinical impact of routine esophagram or endoscopy immediately post-POEM remains unclear. Testing can be considered based on local practice preferences and in cases in which intraprocedural events or postprocedural findings warrant further evaluation.
Proton pump inhibitors are recommended immediately following POEM, as gastroesophageal reflux disease (GERD) is common following POEM, occurring in up to 65% of cases.
Routine endoscopic surveillance is advised to monitor GERD, disease progression, and esophageal cancer risk, which is significantly higher in achalasia patients.
“Just like diabetes and hypertension, we need to remember that achalasia is a chronic disease and long-term postprocedural surveillance is strongly encouraged to monitor disease progression as well as potential complications of reflux,” Yang said.
He noted that surveillance should be considered irrespective of patient symptoms because many of these patients may remain asymptomatic.
“Primary gastroenterologists should have a very low threshold in referring the patient back to the POEM endoscopist or any specialized esophageal center because the ideology of symptoms in these patients can be quite difficult to tease out and often require comprehensive diagnostic workup,” Yang said.
Evidence for POEM in esophagogastric outflow obstruction and other nonachalasia spastic motility disorders is limited and should only be considered on a case-by-case basis after other less invasive approaches have been exhausted, the update states.
For perspective on the POEM clinical practice update, this news organization spoke with Mouen Khashab, MD, director of therapeutic endoscopy, Johns Hopkins University, Baltimore, Maryland.
“The document is very well written and comprehensive,” Khashab said.
However, Khashab said he would have liked to see greater emphasis on the value or role of a short myotomy in the esophagus and cardia.
“There is level I evidence that the short esophageal myotomy is equivalent to a long esophageal myotomy for type I and II achalasia. When you do a short myotomy, you save procedure time and there is potentially a lower incidence of blown-out myotomy or BOM,” Khashab said.
Khashab also noted that a long myotomy on the gastric side “likely increases the risk of reflux disease, and therefore a limited myotomy on the gastric side likely also is advantageous.”
This research had no commercial funding. Yang serves as a consultant for Boston Scientific, Olympus, FujiFilm, Microtech, Medtronic, 3D-Matrix, and Neptune Medical, and has received research support from Microtech and 3D-Matrix. Khashab had no relevant disclosures.
A version of this article appeared on Medscape.com .
The American Gastroenterological Association (AGA) has released
“Any patient suspected to have achalasia, or difficulty swallowing for that matter, should undergo a comprehensive diagnostic workup, and that should include clinical history, review of medication, as well as tests. The diagnosis should not be based on isolated tests but on the clinical picture as a whole,” first author Dennis Yang, MD, AGAF, with the Center for Interventional Endoscopy, AdventHealth, Orlando, Florida, noted in an AGA podcast about the update.
The clinical practice update, published in Gastroenterology, includes 12 “best practice advice” statements.
Since its introduction to clinical practice more than a decade ago, POEM has matured and gained widespread acceptance because of its efficacy and safety profile.
POEM has at least similar outcomes to laparoscopic Heller myotomy and pneumatic dilation for type I and type II achalasia with better results for those with type III achalasia, Yang noted.
“However, besides disease phenotype, we need to remember that choosing the right treatment for the patient is going to be based on multiple factors including patient characteristics as well as local expertise,” Yang added.
In terms of technical considerations, the update states that both anterior and posterior tunnel approaches demonstrate comparable success and postprocedure reflux rates. Tunnel orientation should be tailored to the patient’s surgical history and endoscopist’s preference.
It further states that optimal length of the myotomy in the esophagus and cardia, as it pertains to treatment efficacy and risk for postprocedure reflux, remains to be determined.
Adjunct techniques, including real-time intraprocedure functional luminal impedance planimetry, may be considered to tailor or confirm the adequacy of the myotomy.
Same-day discharge after POEM can be considered in select patients who meet discharge criteria. Patients with advanced age, significant comorbidities, poor social support, and/or access to specialized care should be considered for hospital admission, irrespective of symptoms.
The update notes that specific guidelines on the role and extent of antibiotic prophylaxis before and after POEM are lacking. A single dose of antibiotics at the time of POEM “may be sufficient” for antibiotic prophylaxis.
In terms of immediate post-POEM care, the update notes that the clinical impact of routine esophagram or endoscopy immediately post-POEM remains unclear. Testing can be considered based on local practice preferences and in cases in which intraprocedural events or postprocedural findings warrant further evaluation.
Proton pump inhibitors are recommended immediately following POEM, as gastroesophageal reflux disease (GERD) is common following POEM, occurring in up to 65% of cases.
Routine endoscopic surveillance is advised to monitor GERD, disease progression, and esophageal cancer risk, which is significantly higher in achalasia patients.
“Just like diabetes and hypertension, we need to remember that achalasia is a chronic disease and long-term postprocedural surveillance is strongly encouraged to monitor disease progression as well as potential complications of reflux,” Yang said.
He noted that surveillance should be considered irrespective of patient symptoms because many of these patients may remain asymptomatic.
“Primary gastroenterologists should have a very low threshold in referring the patient back to the POEM endoscopist or any specialized esophageal center because the ideology of symptoms in these patients can be quite difficult to tease out and often require comprehensive diagnostic workup,” Yang said.
Evidence for POEM in esophagogastric outflow obstruction and other nonachalasia spastic motility disorders is limited and should only be considered on a case-by-case basis after other less invasive approaches have been exhausted, the update states.
For perspective on the POEM clinical practice update, this news organization spoke with Mouen Khashab, MD, director of therapeutic endoscopy, Johns Hopkins University, Baltimore, Maryland.
“The document is very well written and comprehensive,” Khashab said.
However, Khashab said he would have liked to see greater emphasis on the value or role of a short myotomy in the esophagus and cardia.
“There is level I evidence that the short esophageal myotomy is equivalent to a long esophageal myotomy for type I and II achalasia. When you do a short myotomy, you save procedure time and there is potentially a lower incidence of blown-out myotomy or BOM,” Khashab said.
Khashab also noted that a long myotomy on the gastric side “likely increases the risk of reflux disease, and therefore a limited myotomy on the gastric side likely also is advantageous.”
This research had no commercial funding. Yang serves as a consultant for Boston Scientific, Olympus, FujiFilm, Microtech, Medtronic, 3D-Matrix, and Neptune Medical, and has received research support from Microtech and 3D-Matrix. Khashab had no relevant disclosures.
A version of this article appeared on Medscape.com .
FROM GASTROENTEROLOGY
Promise for CAR T-Cell Therapies in Solid Tumors?
Chimeric antigen receptor (CAR) T-cell therapy has shown efficacy in blood cancers — with six CAR T-cell products now approved by the Food and Drug Administration (FDA) to treat six hematologic malignancies.
For solid tumors, however, the efficacy of CAR T-cell treatments has been limited and progress “more incremental,” Christian Hinrichs, MD, with Rutgers Cancer Institute in New Brunswick, New Jersey, told this news organization. Currently, there are no CAR T-cell therapies approved in the United States to treat solid tumors.
Why have CAR T-cell therapies been less effective against solid tumors?
Perhaps the biggest hurdle is the ability to identify and selectively target specific molecular structures in cancer cells without causing severe toxicity by injuring healthy cells, Hinrichs and coauthors wrote in a recent JAMA review.
CAR T-cells are made up of “T cells genetically engineered to express a synthetic receptor that recognizes a tumor cell-surface protein,” Hinrichs and colleagues explained. But identifying cell surface antigens that are exclusive to solid tumor cells has been a challenge, which means CAR T-cell therapies end up affecting both tumor and healthy tissues.
“This makes it difficult to target and kill all the tumor cells without causing severe toxicity from injury to healthy cells,” Hinrichs explained.
Other common obstacles include challenges penetrating the dense extracellular matrix of solid tumors and the need to overcome inhibitory cells and molecules in the tumor microenvironment.
Despite the challenges and slow progress, some “promising results” have begun to emerge in the solid tumor, CAR T-cell space, Hinrichs said.
A recent phase 1-2 study, for instance, found that 63% (17 of 27) of pediatric patients with heavily pretreated neuroblastoma achieved an overall response with an investigational CAR T-cell therapy, GD2-CART01.
In a recent phase 1 trial, 38 of 98 patients with gastrointestinal cancers (39%) achieved partial or complete responses after receiving an investigational CAR T-cell treatment directed at Claudin18.2. However, the responses were short overall and could have been related to the chemotherapy given before the CAR T-cell infusion.
Another phase 1 trial found that a GPC3-targeted CAR T-cell therapy led to an objective response rate in half (12 of 24) of heavily treated patients with advanced hepatocellular carcinoma, with a disease control rate of almost 91%.
Outside of CAR-T cell therapies, other cell-based treatments have shown promise against solid tumors, including two T-cell therapies recently approved by the FDA.
Last February, the FDA approved the tumor-infiltrating lymphocyte (TIL) therapy lifileucel (Amtagvi) for advanced melanoma. In August, the agency approved the T-cell receptor (TCR) therapy afamitresgene autoleucel for advanced synovial sarcoma.
“Response rates for these cellular therapies are in the 30% range, but already there is clear data that there’s durability for some patients, which is very exciting because previously treated patients really have very few treatment options,” Jennifer Brudno, MD, with the National Cancer Institute and coauthor of the JAMA review, said in a journal podcast.
Several cell-based agents are in early trials to treat a range of solid tumors.
Hinrichs and colleagues previously reported findings from a phase 2 clinical trial of TIL therapy for human papillomavirus (HPV) — associated cancers including cervical, oropharyngeal, and anal cancers. Responses occurred in 5 of 18 patients with cervical cancer and 2 of 11 patients with noncervical cancers. “Two of the patients with cervical cancer had complete responses that are ongoing years after a single infusion of cells,” Hinrichs told this news organization.
Hinrichs was also involved in a phase 1 trial of gene-engineered TCR T-cells targeting HPV E7 for HPV-associated cancers reported tumor responses in 6 of 12 patients, including 4 of 8 with tumors refractory to checkpoint blockade immunotherapy. A phase 2 trial is now open at Rutgers Cancer Institute, as is an early trial testing a new TCR T-cell therapy targeting Kita-Kyushu Lung Cancer Antigen-1 to treat metastatic gastric, lung, breast, and cervical cancers.
Despite the encouraging findings, for CAR T-cell and other cell-based therapies to be successful against solid tumors, “we need to develop more treatments directed against antigens that are expressed by most or all the cells in a tumor but not by critical healthy tissues,” Hinrichs said.
“It may also be important to increase the potency of therapeutic cells and develop more sophisticated methods of antigen targeting that can better distinguish between tumors and healthy tissues,” he noted.
Brudno reported being an unpaid scientific advisory board member for and receiving travel expenses from Kyverna Therapeutics. Hinrichs reported receiving personal fees from Neogene Therapeutics, Capstan Therapeutics, GlaxoSmithKline, Vir Biotechnology, and PACT Pharma; equity from Scarlet TCR (company officer); and sponsored research agreements from T-Cure Biosciences and Neogene Therapeutics outside the submitted work. He also holds several patents related to cellular therapies.
A version of this article first appeared on Medscape.com.
Chimeric antigen receptor (CAR) T-cell therapy has shown efficacy in blood cancers — with six CAR T-cell products now approved by the Food and Drug Administration (FDA) to treat six hematologic malignancies.
For solid tumors, however, the efficacy of CAR T-cell treatments has been limited and progress “more incremental,” Christian Hinrichs, MD, with Rutgers Cancer Institute in New Brunswick, New Jersey, told this news organization. Currently, there are no CAR T-cell therapies approved in the United States to treat solid tumors.
Why have CAR T-cell therapies been less effective against solid tumors?
Perhaps the biggest hurdle is the ability to identify and selectively target specific molecular structures in cancer cells without causing severe toxicity by injuring healthy cells, Hinrichs and coauthors wrote in a recent JAMA review.
CAR T-cells are made up of “T cells genetically engineered to express a synthetic receptor that recognizes a tumor cell-surface protein,” Hinrichs and colleagues explained. But identifying cell surface antigens that are exclusive to solid tumor cells has been a challenge, which means CAR T-cell therapies end up affecting both tumor and healthy tissues.
“This makes it difficult to target and kill all the tumor cells without causing severe toxicity from injury to healthy cells,” Hinrichs explained.
Other common obstacles include challenges penetrating the dense extracellular matrix of solid tumors and the need to overcome inhibitory cells and molecules in the tumor microenvironment.
Despite the challenges and slow progress, some “promising results” have begun to emerge in the solid tumor, CAR T-cell space, Hinrichs said.
A recent phase 1-2 study, for instance, found that 63% (17 of 27) of pediatric patients with heavily pretreated neuroblastoma achieved an overall response with an investigational CAR T-cell therapy, GD2-CART01.
In a recent phase 1 trial, 38 of 98 patients with gastrointestinal cancers (39%) achieved partial or complete responses after receiving an investigational CAR T-cell treatment directed at Claudin18.2. However, the responses were short overall and could have been related to the chemotherapy given before the CAR T-cell infusion.
Another phase 1 trial found that a GPC3-targeted CAR T-cell therapy led to an objective response rate in half (12 of 24) of heavily treated patients with advanced hepatocellular carcinoma, with a disease control rate of almost 91%.
Outside of CAR-T cell therapies, other cell-based treatments have shown promise against solid tumors, including two T-cell therapies recently approved by the FDA.
Last February, the FDA approved the tumor-infiltrating lymphocyte (TIL) therapy lifileucel (Amtagvi) for advanced melanoma. In August, the agency approved the T-cell receptor (TCR) therapy afamitresgene autoleucel for advanced synovial sarcoma.
“Response rates for these cellular therapies are in the 30% range, but already there is clear data that there’s durability for some patients, which is very exciting because previously treated patients really have very few treatment options,” Jennifer Brudno, MD, with the National Cancer Institute and coauthor of the JAMA review, said in a journal podcast.
Several cell-based agents are in early trials to treat a range of solid tumors.
Hinrichs and colleagues previously reported findings from a phase 2 clinical trial of TIL therapy for human papillomavirus (HPV) — associated cancers including cervical, oropharyngeal, and anal cancers. Responses occurred in 5 of 18 patients with cervical cancer and 2 of 11 patients with noncervical cancers. “Two of the patients with cervical cancer had complete responses that are ongoing years after a single infusion of cells,” Hinrichs told this news organization.
Hinrichs was also involved in a phase 1 trial of gene-engineered TCR T-cells targeting HPV E7 for HPV-associated cancers reported tumor responses in 6 of 12 patients, including 4 of 8 with tumors refractory to checkpoint blockade immunotherapy. A phase 2 trial is now open at Rutgers Cancer Institute, as is an early trial testing a new TCR T-cell therapy targeting Kita-Kyushu Lung Cancer Antigen-1 to treat metastatic gastric, lung, breast, and cervical cancers.
Despite the encouraging findings, for CAR T-cell and other cell-based therapies to be successful against solid tumors, “we need to develop more treatments directed against antigens that are expressed by most or all the cells in a tumor but not by critical healthy tissues,” Hinrichs said.
“It may also be important to increase the potency of therapeutic cells and develop more sophisticated methods of antigen targeting that can better distinguish between tumors and healthy tissues,” he noted.
Brudno reported being an unpaid scientific advisory board member for and receiving travel expenses from Kyverna Therapeutics. Hinrichs reported receiving personal fees from Neogene Therapeutics, Capstan Therapeutics, GlaxoSmithKline, Vir Biotechnology, and PACT Pharma; equity from Scarlet TCR (company officer); and sponsored research agreements from T-Cure Biosciences and Neogene Therapeutics outside the submitted work. He also holds several patents related to cellular therapies.
A version of this article first appeared on Medscape.com.
Chimeric antigen receptor (CAR) T-cell therapy has shown efficacy in blood cancers — with six CAR T-cell products now approved by the Food and Drug Administration (FDA) to treat six hematologic malignancies.
For solid tumors, however, the efficacy of CAR T-cell treatments has been limited and progress “more incremental,” Christian Hinrichs, MD, with Rutgers Cancer Institute in New Brunswick, New Jersey, told this news organization. Currently, there are no CAR T-cell therapies approved in the United States to treat solid tumors.
Why have CAR T-cell therapies been less effective against solid tumors?
Perhaps the biggest hurdle is the ability to identify and selectively target specific molecular structures in cancer cells without causing severe toxicity by injuring healthy cells, Hinrichs and coauthors wrote in a recent JAMA review.
CAR T-cells are made up of “T cells genetically engineered to express a synthetic receptor that recognizes a tumor cell-surface protein,” Hinrichs and colleagues explained. But identifying cell surface antigens that are exclusive to solid tumor cells has been a challenge, which means CAR T-cell therapies end up affecting both tumor and healthy tissues.
“This makes it difficult to target and kill all the tumor cells without causing severe toxicity from injury to healthy cells,” Hinrichs explained.
Other common obstacles include challenges penetrating the dense extracellular matrix of solid tumors and the need to overcome inhibitory cells and molecules in the tumor microenvironment.
Despite the challenges and slow progress, some “promising results” have begun to emerge in the solid tumor, CAR T-cell space, Hinrichs said.
A recent phase 1-2 study, for instance, found that 63% (17 of 27) of pediatric patients with heavily pretreated neuroblastoma achieved an overall response with an investigational CAR T-cell therapy, GD2-CART01.
In a recent phase 1 trial, 38 of 98 patients with gastrointestinal cancers (39%) achieved partial or complete responses after receiving an investigational CAR T-cell treatment directed at Claudin18.2. However, the responses were short overall and could have been related to the chemotherapy given before the CAR T-cell infusion.
Another phase 1 trial found that a GPC3-targeted CAR T-cell therapy led to an objective response rate in half (12 of 24) of heavily treated patients with advanced hepatocellular carcinoma, with a disease control rate of almost 91%.
Outside of CAR-T cell therapies, other cell-based treatments have shown promise against solid tumors, including two T-cell therapies recently approved by the FDA.
Last February, the FDA approved the tumor-infiltrating lymphocyte (TIL) therapy lifileucel (Amtagvi) for advanced melanoma. In August, the agency approved the T-cell receptor (TCR) therapy afamitresgene autoleucel for advanced synovial sarcoma.
“Response rates for these cellular therapies are in the 30% range, but already there is clear data that there’s durability for some patients, which is very exciting because previously treated patients really have very few treatment options,” Jennifer Brudno, MD, with the National Cancer Institute and coauthor of the JAMA review, said in a journal podcast.
Several cell-based agents are in early trials to treat a range of solid tumors.
Hinrichs and colleagues previously reported findings from a phase 2 clinical trial of TIL therapy for human papillomavirus (HPV) — associated cancers including cervical, oropharyngeal, and anal cancers. Responses occurred in 5 of 18 patients with cervical cancer and 2 of 11 patients with noncervical cancers. “Two of the patients with cervical cancer had complete responses that are ongoing years after a single infusion of cells,” Hinrichs told this news organization.
Hinrichs was also involved in a phase 1 trial of gene-engineered TCR T-cells targeting HPV E7 for HPV-associated cancers reported tumor responses in 6 of 12 patients, including 4 of 8 with tumors refractory to checkpoint blockade immunotherapy. A phase 2 trial is now open at Rutgers Cancer Institute, as is an early trial testing a new TCR T-cell therapy targeting Kita-Kyushu Lung Cancer Antigen-1 to treat metastatic gastric, lung, breast, and cervical cancers.
Despite the encouraging findings, for CAR T-cell and other cell-based therapies to be successful against solid tumors, “we need to develop more treatments directed against antigens that are expressed by most or all the cells in a tumor but not by critical healthy tissues,” Hinrichs said.
“It may also be important to increase the potency of therapeutic cells and develop more sophisticated methods of antigen targeting that can better distinguish between tumors and healthy tissues,” he noted.
Brudno reported being an unpaid scientific advisory board member for and receiving travel expenses from Kyverna Therapeutics. Hinrichs reported receiving personal fees from Neogene Therapeutics, Capstan Therapeutics, GlaxoSmithKline, Vir Biotechnology, and PACT Pharma; equity from Scarlet TCR (company officer); and sponsored research agreements from T-Cure Biosciences and Neogene Therapeutics outside the submitted work. He also holds several patents related to cellular therapies.
A version of this article first appeared on Medscape.com.