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Digestive Disease Week (DDW 2013)
More adenomas detected with FUSE endoscope
ORLANDO – Use of a novel colonoscope that offers 330-degree viewing, as compared to the 140- to 170-degree viewing of traditional forward-viewing colonoscopes, was associated with a 71% improvement in adenoma detection, according to late-breaking data from a randomized, prospective multicenter study reported at the annual Digestive Disease Week.
In addition to its expanded viewing capability, the device has the same technical features as traditional colonoscopes, including scope length and diameter, full tip deflection, working channel, suction, and forward water-jet irrigation, reported Dr. Ian M. Gralnek of the Technion-Israel Institute of Technology and Elisha Hospital, both in Haifa, Israel.
For the study, 185 patients underwent colonoscopies via both traditional forward-viewing and EndoChoice’s full-spectrum endoscopy (FUSE) colonoscopy in random order on the same day. The overall polyp detection rate was 52.5%, and the adenoma detection rate was 31.7%.
In 88 subjects who underwent traditional colonoscopy followed by FUSE colonoscopy, traditional colonoscopy detected 28 adenomas and the subsequent FUSE colonoscopy detected an additional 20 adenomas, for a 71.4% increase in adenomas found with subsequent FUSE colonoscopy.
In 97 subjects who were randomly assigned to receive FUSE colonoscopy first, 59 adenomas and 2 cancers were detected. On subsequent traditional colonoscopy, 5 additional adenomas were found, yielding an 8.2% increase in adenomas found with subsequent traditional colonoscopy.
Thus, significantly more adenomas were detected by FUSE colonoscopy than with traditional colonoscopy (71.4% vs. 8.2% incremental detection rates), and significantly fewer adenomas were missed by FUSE colonoscopy as compared with traditional colonoscopy (7.6% vs. 42%).
The differences were highly statistically significant, Dr. Gralnek said.
Study subjects were adults aged 18-70 years who were referred between January 2012 and March 2013 for colorectal cancer screening, polyp surveillance, or diagnostic evaluation to one of three sites in Israel, one site in the Netherlands, or two in the United States. Subjects were randomly assigned to receive FUSE or traditional colonoscopy, then to receive the alternative modality on the same day. The same endoscopist performed both examinations.
Though the study findings are limited by the lack of blinding, the fact that the same endoscopist performed both colonoscopies in each patient, and the lack of per-patient analysis, the results highlight the value of the improved visualization afforded by the FUSE colonoscope, Dr. Gralnek concluded.
Developed by EndoChoice, the FUSE colonoscope has a CE marking in Europe, and it recently received 510(k) marketing approval from the U.S. Food and Drug Administration. Commercial availability is expected as early as summer 2013.
The study was sponsored by EndoChoice.
Dr. Gralnek is a member of advisory committees or review panels for Given Imaging and Motus GI, and is a consultant for Given Imaging, Peer Medical, and AstraZeneca.
ORLANDO – Use of a novel colonoscope that offers 330-degree viewing, as compared to the 140- to 170-degree viewing of traditional forward-viewing colonoscopes, was associated with a 71% improvement in adenoma detection, according to late-breaking data from a randomized, prospective multicenter study reported at the annual Digestive Disease Week.
In addition to its expanded viewing capability, the device has the same technical features as traditional colonoscopes, including scope length and diameter, full tip deflection, working channel, suction, and forward water-jet irrigation, reported Dr. Ian M. Gralnek of the Technion-Israel Institute of Technology and Elisha Hospital, both in Haifa, Israel.
For the study, 185 patients underwent colonoscopies via both traditional forward-viewing and EndoChoice’s full-spectrum endoscopy (FUSE) colonoscopy in random order on the same day. The overall polyp detection rate was 52.5%, and the adenoma detection rate was 31.7%.
In 88 subjects who underwent traditional colonoscopy followed by FUSE colonoscopy, traditional colonoscopy detected 28 adenomas and the subsequent FUSE colonoscopy detected an additional 20 adenomas, for a 71.4% increase in adenomas found with subsequent FUSE colonoscopy.
In 97 subjects who were randomly assigned to receive FUSE colonoscopy first, 59 adenomas and 2 cancers were detected. On subsequent traditional colonoscopy, 5 additional adenomas were found, yielding an 8.2% increase in adenomas found with subsequent traditional colonoscopy.
Thus, significantly more adenomas were detected by FUSE colonoscopy than with traditional colonoscopy (71.4% vs. 8.2% incremental detection rates), and significantly fewer adenomas were missed by FUSE colonoscopy as compared with traditional colonoscopy (7.6% vs. 42%).
The differences were highly statistically significant, Dr. Gralnek said.
Study subjects were adults aged 18-70 years who were referred between January 2012 and March 2013 for colorectal cancer screening, polyp surveillance, or diagnostic evaluation to one of three sites in Israel, one site in the Netherlands, or two in the United States. Subjects were randomly assigned to receive FUSE or traditional colonoscopy, then to receive the alternative modality on the same day. The same endoscopist performed both examinations.
Though the study findings are limited by the lack of blinding, the fact that the same endoscopist performed both colonoscopies in each patient, and the lack of per-patient analysis, the results highlight the value of the improved visualization afforded by the FUSE colonoscope, Dr. Gralnek concluded.
Developed by EndoChoice, the FUSE colonoscope has a CE marking in Europe, and it recently received 510(k) marketing approval from the U.S. Food and Drug Administration. Commercial availability is expected as early as summer 2013.
The study was sponsored by EndoChoice.
Dr. Gralnek is a member of advisory committees or review panels for Given Imaging and Motus GI, and is a consultant for Given Imaging, Peer Medical, and AstraZeneca.
ORLANDO – Use of a novel colonoscope that offers 330-degree viewing, as compared to the 140- to 170-degree viewing of traditional forward-viewing colonoscopes, was associated with a 71% improvement in adenoma detection, according to late-breaking data from a randomized, prospective multicenter study reported at the annual Digestive Disease Week.
In addition to its expanded viewing capability, the device has the same technical features as traditional colonoscopes, including scope length and diameter, full tip deflection, working channel, suction, and forward water-jet irrigation, reported Dr. Ian M. Gralnek of the Technion-Israel Institute of Technology and Elisha Hospital, both in Haifa, Israel.
For the study, 185 patients underwent colonoscopies via both traditional forward-viewing and EndoChoice’s full-spectrum endoscopy (FUSE) colonoscopy in random order on the same day. The overall polyp detection rate was 52.5%, and the adenoma detection rate was 31.7%.
In 88 subjects who underwent traditional colonoscopy followed by FUSE colonoscopy, traditional colonoscopy detected 28 adenomas and the subsequent FUSE colonoscopy detected an additional 20 adenomas, for a 71.4% increase in adenomas found with subsequent FUSE colonoscopy.
In 97 subjects who were randomly assigned to receive FUSE colonoscopy first, 59 adenomas and 2 cancers were detected. On subsequent traditional colonoscopy, 5 additional adenomas were found, yielding an 8.2% increase in adenomas found with subsequent traditional colonoscopy.
Thus, significantly more adenomas were detected by FUSE colonoscopy than with traditional colonoscopy (71.4% vs. 8.2% incremental detection rates), and significantly fewer adenomas were missed by FUSE colonoscopy as compared with traditional colonoscopy (7.6% vs. 42%).
The differences were highly statistically significant, Dr. Gralnek said.
Study subjects were adults aged 18-70 years who were referred between January 2012 and March 2013 for colorectal cancer screening, polyp surveillance, or diagnostic evaluation to one of three sites in Israel, one site in the Netherlands, or two in the United States. Subjects were randomly assigned to receive FUSE or traditional colonoscopy, then to receive the alternative modality on the same day. The same endoscopist performed both examinations.
Though the study findings are limited by the lack of blinding, the fact that the same endoscopist performed both colonoscopies in each patient, and the lack of per-patient analysis, the results highlight the value of the improved visualization afforded by the FUSE colonoscope, Dr. Gralnek concluded.
Developed by EndoChoice, the FUSE colonoscope has a CE marking in Europe, and it recently received 510(k) marketing approval from the U.S. Food and Drug Administration. Commercial availability is expected as early as summer 2013.
The study was sponsored by EndoChoice.
Dr. Gralnek is a member of advisory committees or review panels for Given Imaging and Motus GI, and is a consultant for Given Imaging, Peer Medical, and AstraZeneca.
AT DDW 2013
Major finding: In 88 subjects who underwent traditional forward-viewing colonoscopy followed by FUSE colonoscopy, traditional colonoscopy detected 28 adenomas and the subsequent FUSE colonoscopy detected an additional 20 adenomas.
Data source: A randomized, prospective, multicenter study involving 185 patients who underwent both procedures on the same day, by the same endoscopist.
Disclosures: Dr. Gralnek is a member of advisory committees or review panels for Given Imaging and Motus GI, and is a consultant for Given Imaging, Peer Medical, and AstraZeneca.
Nighttime cholecystectomy may increase complication risk
ORLANDO – Older age and nighttime surgery were associated with an increased risk of complications in patients undergoing laparoscopic cholecystectomy at a high-volume safety net hospital, according to a retrospective study of cases.
Of 576 operations performed in consecutive patients for whom relevant data were available, 35% were performed at night, and although about 60% of procedures overall were nonelective, more than 90% of those performed at night were nonelective, meaning that most patients were admitted directly from the emergency department, Dr. Uma R. Phatak reported at the annual Digestive Disease Week.
A total of 35 complications occurred in 22 patients, including 18 undergoing nonelective surgery and 4 undergoing elective surgery.
Multivariate analysis demonstrated that age and nighttime surgery were significant predictors of complications, said Dr. Phatak of the University of Texas Health Science Center, Houston.
The probability of a complication increased with age for both the patients who underwent daytime surgery and those who underwent nighttime surgery, but the increase was greater in the nighttime surgery group, she said.
The predicted probability of a complication increased threefold for older patients who underwent surgery at night, according to an analysis by 10-year age intervals.
"At the upper end of the age spectrum, the predicted probability of a complication with surgery at night is about 30%, compared to about 10% in the daytime group," Dr. Phatak said.
This analysis did not adjust for disease severity, but a multivariate model that included the elective surgery patients showed that even in this group, an increased risk of a complication was associated with nighttime surgery and increasing age, she noted.
Patients included in the study underwent surgery during an 8-month period from October 2010 to May 2011 at a hospital with a large Hispanic population at high risk for gallstones where laparoscopic cholecystectomy is commonly performed at night. Most (84%) were women, and most (84%) were Hispanic.
The most common diagnoses were acute cholecystitis in the nighttime group and chronic cholecystitis in the daytime group.
Those who underwent nighttime surgery had a lower median age and a longer median length of stay, although it was unclear whether the length of stay was increased due to a delay in getting to the operating room.
The study is limited by its single-center retrospective design, which limits the generalizability. It also was underpowered to detect significant differences in complications other than surgical site infections, Dr. Phatak noted.
Nonetheless, the study demonstrates an increased risk of complications with nighttime surgery, suggesting that the benefits of early laparoscopic cholecystectomy for acute cholecystitis must be balanced against the risk of nighttime surgery, Dr. Phatak said.
"At our institution, new ambulatory operating rooms will be opening soon, decreasing the burden on the main operating room. This will allow for nonemergent cases to be booked during the daytime without imposing delays in the elective schedule," she said.
Providing increased space for elective operations, identifying high-risk patients, and prioritizing surgeries during the day for those patients may decrease the complication rate and improve outcomes, she concluded.
Dr. Phatak reported having no disclosures.
The report by Dr. Phatak and her colleagues
from the University of Texas (UT) Health
Science Center,
Houston, raises
a key issue with respect to the management of acute cholecystitis. Should these
operations be performed at night, especially in older patients? Multiple
prospective, randomized trials over the past 4 decades have concluded that
patients with acute cholecystitis who present within the first few days of the
illness should be managed urgently rather than undergo surgery 6 weeks later.
Nevertheless, a significant proportion of these operations are delayed in the United States.
The question then becomes why is evidence-based practice not being performed?
The answers probably include the surgeon’s schedule, daytime operating room
availability, and staff expertise and equipment availability at night. When an
urgent operation is delayed until the middle of the night, is the patient best
served if her surgeon is overly tired? Similarly, should the next morning’s
patient scheduled for an elective procedure undergo an operation by a surgeon
who has not had an adequate night’s sleep?
The obvious answers to these questions is no, but the
solutions are not simple. Multisurgeon groups and Acute Care Surgery services
may address these issues is schedules are constructed appropriately.
Similarly, efficient management of an operating room
during the day with flexibility for the add-on of urgent cases is ideal. In
addition, cross-training of operating room staff with knowledge and
availability of proper equipment at night is not trivial but is key for safe patient
care. Another important point is whether the findings of the report by Dr.
Phatak are generalizable. Certainly, her observations apply to safety-net
hospitals in cities with large Hispanic populations. However, a 60% incidence
of “nonelective” gallbladder surgery is unusual for the typical community
hospital, rural hospital, or academic medical center. In these settings,
appropriate management of acute cholecystitis is to have the patient take
nothing by mouth (NPO), to initiate appropriate medications, and to schedule
surgery semiurgently, ideally during the daytime. While this ideal situation
may not always be possible, insistence on daytime surgery should be a major
principle especially in older, more frail patients.
Dr. Henry
A. Pitt is an ACS Fellow and vice chairman of surgery at Indiana University, Indianapolis. Dr. Pitt has
no disclosures.
The report by Dr. Phatak and her colleagues
from the University of Texas (UT) Health
Science Center,
Houston, raises
a key issue with respect to the management of acute cholecystitis. Should these
operations be performed at night, especially in older patients? Multiple
prospective, randomized trials over the past 4 decades have concluded that
patients with acute cholecystitis who present within the first few days of the
illness should be managed urgently rather than undergo surgery 6 weeks later.
Nevertheless, a significant proportion of these operations are delayed in the United States.
The question then becomes why is evidence-based practice not being performed?
The answers probably include the surgeon’s schedule, daytime operating room
availability, and staff expertise and equipment availability at night. When an
urgent operation is delayed until the middle of the night, is the patient best
served if her surgeon is overly tired? Similarly, should the next morning’s
patient scheduled for an elective procedure undergo an operation by a surgeon
who has not had an adequate night’s sleep?
The obvious answers to these questions is no, but the
solutions are not simple. Multisurgeon groups and Acute Care Surgery services
may address these issues is schedules are constructed appropriately.
Similarly, efficient management of an operating room
during the day with flexibility for the add-on of urgent cases is ideal. In
addition, cross-training of operating room staff with knowledge and
availability of proper equipment at night is not trivial but is key for safe patient
care. Another important point is whether the findings of the report by Dr.
Phatak are generalizable. Certainly, her observations apply to safety-net
hospitals in cities with large Hispanic populations. However, a 60% incidence
of “nonelective” gallbladder surgery is unusual for the typical community
hospital, rural hospital, or academic medical center. In these settings,
appropriate management of acute cholecystitis is to have the patient take
nothing by mouth (NPO), to initiate appropriate medications, and to schedule
surgery semiurgently, ideally during the daytime. While this ideal situation
may not always be possible, insistence on daytime surgery should be a major
principle especially in older, more frail patients.
Dr. Henry
A. Pitt is an ACS Fellow and vice chairman of surgery at Indiana University, Indianapolis. Dr. Pitt has
no disclosures.
The report by Dr. Phatak and her colleagues
from the University of Texas (UT) Health
Science Center,
Houston, raises
a key issue with respect to the management of acute cholecystitis. Should these
operations be performed at night, especially in older patients? Multiple
prospective, randomized trials over the past 4 decades have concluded that
patients with acute cholecystitis who present within the first few days of the
illness should be managed urgently rather than undergo surgery 6 weeks later.
Nevertheless, a significant proportion of these operations are delayed in the United States.
The question then becomes why is evidence-based practice not being performed?
The answers probably include the surgeon’s schedule, daytime operating room
availability, and staff expertise and equipment availability at night. When an
urgent operation is delayed until the middle of the night, is the patient best
served if her surgeon is overly tired? Similarly, should the next morning’s
patient scheduled for an elective procedure undergo an operation by a surgeon
who has not had an adequate night’s sleep?
The obvious answers to these questions is no, but the
solutions are not simple. Multisurgeon groups and Acute Care Surgery services
may address these issues is schedules are constructed appropriately.
Similarly, efficient management of an operating room
during the day with flexibility for the add-on of urgent cases is ideal. In
addition, cross-training of operating room staff with knowledge and
availability of proper equipment at night is not trivial but is key for safe patient
care. Another important point is whether the findings of the report by Dr.
Phatak are generalizable. Certainly, her observations apply to safety-net
hospitals in cities with large Hispanic populations. However, a 60% incidence
of “nonelective” gallbladder surgery is unusual for the typical community
hospital, rural hospital, or academic medical center. In these settings,
appropriate management of acute cholecystitis is to have the patient take
nothing by mouth (NPO), to initiate appropriate medications, and to schedule
surgery semiurgently, ideally during the daytime. While this ideal situation
may not always be possible, insistence on daytime surgery should be a major
principle especially in older, more frail patients.
Dr. Henry
A. Pitt is an ACS Fellow and vice chairman of surgery at Indiana University, Indianapolis. Dr. Pitt has
no disclosures.
ORLANDO – Older age and nighttime surgery were associated with an increased risk of complications in patients undergoing laparoscopic cholecystectomy at a high-volume safety net hospital, according to a retrospective study of cases.
Of 576 operations performed in consecutive patients for whom relevant data were available, 35% were performed at night, and although about 60% of procedures overall were nonelective, more than 90% of those performed at night were nonelective, meaning that most patients were admitted directly from the emergency department, Dr. Uma R. Phatak reported at the annual Digestive Disease Week.
A total of 35 complications occurred in 22 patients, including 18 undergoing nonelective surgery and 4 undergoing elective surgery.
Multivariate analysis demonstrated that age and nighttime surgery were significant predictors of complications, said Dr. Phatak of the University of Texas Health Science Center, Houston.
The probability of a complication increased with age for both the patients who underwent daytime surgery and those who underwent nighttime surgery, but the increase was greater in the nighttime surgery group, she said.
The predicted probability of a complication increased threefold for older patients who underwent surgery at night, according to an analysis by 10-year age intervals.
"At the upper end of the age spectrum, the predicted probability of a complication with surgery at night is about 30%, compared to about 10% in the daytime group," Dr. Phatak said.
This analysis did not adjust for disease severity, but a multivariate model that included the elective surgery patients showed that even in this group, an increased risk of a complication was associated with nighttime surgery and increasing age, she noted.
Patients included in the study underwent surgery during an 8-month period from October 2010 to May 2011 at a hospital with a large Hispanic population at high risk for gallstones where laparoscopic cholecystectomy is commonly performed at night. Most (84%) were women, and most (84%) were Hispanic.
The most common diagnoses were acute cholecystitis in the nighttime group and chronic cholecystitis in the daytime group.
Those who underwent nighttime surgery had a lower median age and a longer median length of stay, although it was unclear whether the length of stay was increased due to a delay in getting to the operating room.
The study is limited by its single-center retrospective design, which limits the generalizability. It also was underpowered to detect significant differences in complications other than surgical site infections, Dr. Phatak noted.
Nonetheless, the study demonstrates an increased risk of complications with nighttime surgery, suggesting that the benefits of early laparoscopic cholecystectomy for acute cholecystitis must be balanced against the risk of nighttime surgery, Dr. Phatak said.
"At our institution, new ambulatory operating rooms will be opening soon, decreasing the burden on the main operating room. This will allow for nonemergent cases to be booked during the daytime without imposing delays in the elective schedule," she said.
Providing increased space for elective operations, identifying high-risk patients, and prioritizing surgeries during the day for those patients may decrease the complication rate and improve outcomes, she concluded.
Dr. Phatak reported having no disclosures.
ORLANDO – Older age and nighttime surgery were associated with an increased risk of complications in patients undergoing laparoscopic cholecystectomy at a high-volume safety net hospital, according to a retrospective study of cases.
Of 576 operations performed in consecutive patients for whom relevant data were available, 35% were performed at night, and although about 60% of procedures overall were nonelective, more than 90% of those performed at night were nonelective, meaning that most patients were admitted directly from the emergency department, Dr. Uma R. Phatak reported at the annual Digestive Disease Week.
A total of 35 complications occurred in 22 patients, including 18 undergoing nonelective surgery and 4 undergoing elective surgery.
Multivariate analysis demonstrated that age and nighttime surgery were significant predictors of complications, said Dr. Phatak of the University of Texas Health Science Center, Houston.
The probability of a complication increased with age for both the patients who underwent daytime surgery and those who underwent nighttime surgery, but the increase was greater in the nighttime surgery group, she said.
The predicted probability of a complication increased threefold for older patients who underwent surgery at night, according to an analysis by 10-year age intervals.
"At the upper end of the age spectrum, the predicted probability of a complication with surgery at night is about 30%, compared to about 10% in the daytime group," Dr. Phatak said.
This analysis did not adjust for disease severity, but a multivariate model that included the elective surgery patients showed that even in this group, an increased risk of a complication was associated with nighttime surgery and increasing age, she noted.
Patients included in the study underwent surgery during an 8-month period from October 2010 to May 2011 at a hospital with a large Hispanic population at high risk for gallstones where laparoscopic cholecystectomy is commonly performed at night. Most (84%) were women, and most (84%) were Hispanic.
The most common diagnoses were acute cholecystitis in the nighttime group and chronic cholecystitis in the daytime group.
Those who underwent nighttime surgery had a lower median age and a longer median length of stay, although it was unclear whether the length of stay was increased due to a delay in getting to the operating room.
The study is limited by its single-center retrospective design, which limits the generalizability. It also was underpowered to detect significant differences in complications other than surgical site infections, Dr. Phatak noted.
Nonetheless, the study demonstrates an increased risk of complications with nighttime surgery, suggesting that the benefits of early laparoscopic cholecystectomy for acute cholecystitis must be balanced against the risk of nighttime surgery, Dr. Phatak said.
"At our institution, new ambulatory operating rooms will be opening soon, decreasing the burden on the main operating room. This will allow for nonemergent cases to be booked during the daytime without imposing delays in the elective schedule," she said.
Providing increased space for elective operations, identifying high-risk patients, and prioritizing surgeries during the day for those patients may decrease the complication rate and improve outcomes, she concluded.
Dr. Phatak reported having no disclosures.
AT DDW 2013
Major finding: Older nighttime cholecystectomy patients had a threefold increased risk for complications.
Data source: A retrospective study of 576 cases.
Disclosures: Dr. Phatak reported having no disclosures.
Skip the sphincterotomy before bile duct stent placement
ORLANDO – Patients with unresectable pancreatic cancer may be safely spared from endoscopic sphincterotomy prior to stent placement, investigators said at the annual Digestive Disease Week.
Among patients undergoing placement of a self-expanding, 10-mm-diameter stent into the bile duct*, there were no differences in the rates of early or late complications between patients randomized to receive endoscopic sphincterotomy (ES) before stent placement and those who underwent stent placement alone, reported Dr. Tsuyoshi Hayashi from Sapporo Medical University in Japan.
"ES had no effect on not only the incidence of complications but also SEMS [self-expanding metal stent] patency and patient survival. ES is an unnecessary pretreatment prior to SEMS placement for distal biliary obstruction due to pancreatic cancer," Dr. Hayashi said.
Although endoscopic sphincterotomy is intended to prevent potential pancreatitis from the expansion forces of the stent on the opening of the pancreatic duct, it adds significantly to operative time and carries the risk of bleeding or perforation, Dr. Hayashi said.
To see whether the endoscopist could safely forego sphincterotomy, investigators in 25 hospitals on Japan’s northern island of Hokkaido enrolled a total of 200 patients into a randomized trial and assigned them to stent placement with or without sphincterotomy. Four patients assigned to sphincterotomy and two assigned to stenting alone were unable to undergo biliary cannulation, leaving 96 and 98 patients, respectively, for the analysis.
The authors found that sphincterotomy added significantly to the procedural time, at a mean of 577 (plus or minus 310) seconds, compared with 388 (plus or minus 203) seconds for the no-sphincterotomy procedures.
But when they looked at early complications (within 30 days of the procedure), they found that there were no significant between-group differences in the rates of mild to severe pancreatitis, moderate bleeding, mild perforation, moderate hepatic abscess, pain, or vomiting.
In addition, there were no significant between-group differences in late complications, including either mild to severe cholecystitis, pancreatitis, bleeding, or duodenal ulcer. Similarly, there were no significant differences between the sphincterotomy group and the no-sphincterotomy group in either median time to stent dysfunction (170.5 vs. 148.0 days, respectively) or median overall survival (242 vs. 202 days).
Causes of stent dysfunction, which occurred in 25 patients in each group, included food impaction, sludge formation, intestinal obstruction, migration, and tumor ingrowth or overgrowth, but there were no significant between-group differences in the causes.
The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.
*Correction 7/25/2013: An earlier version of this story missnamed this duct and stent.
For patients with unresectable pancreatic cancer, self-expandable metallic stents (SEMS) are preferred to smaller-caliber, plastic stents for the palliation of jaundice. SEMS have longer patency rates and reduce the overall costs of care by obviating the need for stent exchanges in the majority of cases. Further, SEMS have largely replaced surgical bypass of the bile duct because of reduced morbidity and acceptable durability since most patients with unresectable pancreatic cancer are not expected to survive more than 1 year.
The decision to place a SEMS with complete or partial coating, primarily designed to reduce the likelihood of tumor ingrowth within the interstices of the stent, is more complex. Coating reduces ingrowth and modestly prolongs patency, but increases the likelihood of stent migration and possibly cholecystitis (due to occlusion of the cystic duct). Presumably due to their larger diameter than plastic stents, previous studies suggested a higher rate of post-ERCP (post-endoscopic retrograde cholangiopancreatography) pancreatitis, irrespective of preexisting endoscopic sphincterotomy.
 |
| Dr. Gregory Cote |
Second, pancreatitis rates of 8%-9% are higher than expected for a low-risk indication such as malignant bile duct obstruction. The higher rates in this trial may be related to study design (patients in clinical trials are expected to have higher event rates due to meticulous follow-up compared with retrospective studies), use of SEMS in all patients, and specificity of the definition of post-ERCP pancreatitis in this population: Patients with pancreatic cancer are more likely to complain of pain following ERCP that is related to expansion of the metal stent, and a rise in serum pancreatic enzymes that may not necessarily connote true acute pancreatitis. This requires further investigation.
Third, bleeding and perforation are uncommon complications of ERCP with or without sphincterotomy when a high-volume physician performs the procedure. These data corroborate this - the argument that skipping the sphincterotomy will lower an already rare set of events is challenging. In fact, the only observed perforation occurred in a patient randomized to no sphincterotomy! Last, the higher rates (albeit not statistically significant) of hepatic abscess and cholecystitis among patients who did not undergo a sphincterotomy should not be ignored.
In some cases, sphincterotomy facilitates passage of the stent delivery catheter and tissue sampling devices, if needed. Nevertheless, endoscopists should be reassured by the equivalent rates of pancreatitis in this clinical trial. Based on these results, it seems appropriate to withhold sphincterotomy, at least in cases where bleeding may be high risk (e.g., with ongoing use of antiplatelet or anticoagulant medications).
Dr. Gregory A. Cote is an assistant professor of medicine in the department of medicine, division of gastroenterology and hepatology, Indiana University School of Medicine, Indianapolis. He is a consultant and member of the advisory board for Boston Scientific and a member of the advisory board for Olympus America.
For patients with unresectable pancreatic cancer, self-expandable metallic stents (SEMS) are preferred to smaller-caliber, plastic stents for the palliation of jaundice. SEMS have longer patency rates and reduce the overall costs of care by obviating the need for stent exchanges in the majority of cases. Further, SEMS have largely replaced surgical bypass of the bile duct because of reduced morbidity and acceptable durability since most patients with unresectable pancreatic cancer are not expected to survive more than 1 year.
The decision to place a SEMS with complete or partial coating, primarily designed to reduce the likelihood of tumor ingrowth within the interstices of the stent, is more complex. Coating reduces ingrowth and modestly prolongs patency, but increases the likelihood of stent migration and possibly cholecystitis (due to occlusion of the cystic duct). Presumably due to their larger diameter than plastic stents, previous studies suggested a higher rate of post-ERCP (post-endoscopic retrograde cholangiopancreatography) pancreatitis, irrespective of preexisting endoscopic sphincterotomy.
|
| Dr. Gregory Cote |
Second, pancreatitis rates of 8%-9% are higher than expected for a low-risk indication such as malignant bile duct obstruction. The higher rates in this trial may be related to study design (patients in clinical trials are expected to have higher event rates due to meticulous follow-up compared with retrospective studies), use of SEMS in all patients, and specificity of the definition of post-ERCP pancreatitis in this population: Patients with pancreatic cancer are more likely to complain of pain following ERCP that is related to expansion of the metal stent, and a rise in serum pancreatic enzymes that may not necessarily connote true acute pancreatitis. This requires further investigation.
Third, bleeding and perforation are uncommon complications of ERCP with or without sphincterotomy when a high-volume physician performs the procedure. These data corroborate this - the argument that skipping the sphincterotomy will lower an already rare set of events is challenging. In fact, the only observed perforation occurred in a patient randomized to no sphincterotomy! Last, the higher rates (albeit not statistically significant) of hepatic abscess and cholecystitis among patients who did not undergo a sphincterotomy should not be ignored.
In some cases, sphincterotomy facilitates passage of the stent delivery catheter and tissue sampling devices, if needed. Nevertheless, endoscopists should be reassured by the equivalent rates of pancreatitis in this clinical trial. Based on these results, it seems appropriate to withhold sphincterotomy, at least in cases where bleeding may be high risk (e.g., with ongoing use of antiplatelet or anticoagulant medications).
Dr. Gregory A. Cote is an assistant professor of medicine in the department of medicine, division of gastroenterology and hepatology, Indiana University School of Medicine, Indianapolis. He is a consultant and member of the advisory board for Boston Scientific and a member of the advisory board for Olympus America.
For patients with unresectable pancreatic cancer, self-expandable metallic stents (SEMS) are preferred to smaller-caliber, plastic stents for the palliation of jaundice. SEMS have longer patency rates and reduce the overall costs of care by obviating the need for stent exchanges in the majority of cases. Further, SEMS have largely replaced surgical bypass of the bile duct because of reduced morbidity and acceptable durability since most patients with unresectable pancreatic cancer are not expected to survive more than 1 year.
The decision to place a SEMS with complete or partial coating, primarily designed to reduce the likelihood of tumor ingrowth within the interstices of the stent, is more complex. Coating reduces ingrowth and modestly prolongs patency, but increases the likelihood of stent migration and possibly cholecystitis (due to occlusion of the cystic duct). Presumably due to their larger diameter than plastic stents, previous studies suggested a higher rate of post-ERCP (post-endoscopic retrograde cholangiopancreatography) pancreatitis, irrespective of preexisting endoscopic sphincterotomy.
|
| Dr. Gregory Cote |
Second, pancreatitis rates of 8%-9% are higher than expected for a low-risk indication such as malignant bile duct obstruction. The higher rates in this trial may be related to study design (patients in clinical trials are expected to have higher event rates due to meticulous follow-up compared with retrospective studies), use of SEMS in all patients, and specificity of the definition of post-ERCP pancreatitis in this population: Patients with pancreatic cancer are more likely to complain of pain following ERCP that is related to expansion of the metal stent, and a rise in serum pancreatic enzymes that may not necessarily connote true acute pancreatitis. This requires further investigation.
Third, bleeding and perforation are uncommon complications of ERCP with or without sphincterotomy when a high-volume physician performs the procedure. These data corroborate this - the argument that skipping the sphincterotomy will lower an already rare set of events is challenging. In fact, the only observed perforation occurred in a patient randomized to no sphincterotomy! Last, the higher rates (albeit not statistically significant) of hepatic abscess and cholecystitis among patients who did not undergo a sphincterotomy should not be ignored.
In some cases, sphincterotomy facilitates passage of the stent delivery catheter and tissue sampling devices, if needed. Nevertheless, endoscopists should be reassured by the equivalent rates of pancreatitis in this clinical trial. Based on these results, it seems appropriate to withhold sphincterotomy, at least in cases where bleeding may be high risk (e.g., with ongoing use of antiplatelet or anticoagulant medications).
Dr. Gregory A. Cote is an assistant professor of medicine in the department of medicine, division of gastroenterology and hepatology, Indiana University School of Medicine, Indianapolis. He is a consultant and member of the advisory board for Boston Scientific and a member of the advisory board for Olympus America.
ORLANDO – Patients with unresectable pancreatic cancer may be safely spared from endoscopic sphincterotomy prior to stent placement, investigators said at the annual Digestive Disease Week.
Among patients undergoing placement of a self-expanding, 10-mm-diameter stent into the bile duct*, there were no differences in the rates of early or late complications between patients randomized to receive endoscopic sphincterotomy (ES) before stent placement and those who underwent stent placement alone, reported Dr. Tsuyoshi Hayashi from Sapporo Medical University in Japan.
"ES had no effect on not only the incidence of complications but also SEMS [self-expanding metal stent] patency and patient survival. ES is an unnecessary pretreatment prior to SEMS placement for distal biliary obstruction due to pancreatic cancer," Dr. Hayashi said.
Although endoscopic sphincterotomy is intended to prevent potential pancreatitis from the expansion forces of the stent on the opening of the pancreatic duct, it adds significantly to operative time and carries the risk of bleeding or perforation, Dr. Hayashi said.
To see whether the endoscopist could safely forego sphincterotomy, investigators in 25 hospitals on Japan’s northern island of Hokkaido enrolled a total of 200 patients into a randomized trial and assigned them to stent placement with or without sphincterotomy. Four patients assigned to sphincterotomy and two assigned to stenting alone were unable to undergo biliary cannulation, leaving 96 and 98 patients, respectively, for the analysis.
The authors found that sphincterotomy added significantly to the procedural time, at a mean of 577 (plus or minus 310) seconds, compared with 388 (plus or minus 203) seconds for the no-sphincterotomy procedures.
But when they looked at early complications (within 30 days of the procedure), they found that there were no significant between-group differences in the rates of mild to severe pancreatitis, moderate bleeding, mild perforation, moderate hepatic abscess, pain, or vomiting.
In addition, there were no significant between-group differences in late complications, including either mild to severe cholecystitis, pancreatitis, bleeding, or duodenal ulcer. Similarly, there were no significant differences between the sphincterotomy group and the no-sphincterotomy group in either median time to stent dysfunction (170.5 vs. 148.0 days, respectively) or median overall survival (242 vs. 202 days).
Causes of stent dysfunction, which occurred in 25 patients in each group, included food impaction, sludge formation, intestinal obstruction, migration, and tumor ingrowth or overgrowth, but there were no significant between-group differences in the causes.
The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.
*Correction 7/25/2013: An earlier version of this story missnamed this duct and stent.
ORLANDO – Patients with unresectable pancreatic cancer may be safely spared from endoscopic sphincterotomy prior to stent placement, investigators said at the annual Digestive Disease Week.
Among patients undergoing placement of a self-expanding, 10-mm-diameter stent into the bile duct*, there were no differences in the rates of early or late complications between patients randomized to receive endoscopic sphincterotomy (ES) before stent placement and those who underwent stent placement alone, reported Dr. Tsuyoshi Hayashi from Sapporo Medical University in Japan.
"ES had no effect on not only the incidence of complications but also SEMS [self-expanding metal stent] patency and patient survival. ES is an unnecessary pretreatment prior to SEMS placement for distal biliary obstruction due to pancreatic cancer," Dr. Hayashi said.
Although endoscopic sphincterotomy is intended to prevent potential pancreatitis from the expansion forces of the stent on the opening of the pancreatic duct, it adds significantly to operative time and carries the risk of bleeding or perforation, Dr. Hayashi said.
To see whether the endoscopist could safely forego sphincterotomy, investigators in 25 hospitals on Japan’s northern island of Hokkaido enrolled a total of 200 patients into a randomized trial and assigned them to stent placement with or without sphincterotomy. Four patients assigned to sphincterotomy and two assigned to stenting alone were unable to undergo biliary cannulation, leaving 96 and 98 patients, respectively, for the analysis.
The authors found that sphincterotomy added significantly to the procedural time, at a mean of 577 (plus or minus 310) seconds, compared with 388 (plus or minus 203) seconds for the no-sphincterotomy procedures.
But when they looked at early complications (within 30 days of the procedure), they found that there were no significant between-group differences in the rates of mild to severe pancreatitis, moderate bleeding, mild perforation, moderate hepatic abscess, pain, or vomiting.
In addition, there were no significant between-group differences in late complications, including either mild to severe cholecystitis, pancreatitis, bleeding, or duodenal ulcer. Similarly, there were no significant differences between the sphincterotomy group and the no-sphincterotomy group in either median time to stent dysfunction (170.5 vs. 148.0 days, respectively) or median overall survival (242 vs. 202 days).
Causes of stent dysfunction, which occurred in 25 patients in each group, included food impaction, sludge formation, intestinal obstruction, migration, and tumor ingrowth or overgrowth, but there were no significant between-group differences in the causes.
The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.
*Correction 7/25/2013: An earlier version of this story missnamed this duct and stent.
AT DDW 2013
Major finding: There were no significant differences in early or late complications among patients with pancreatic cancer who underwent stent placement with or without sphincterotomy.
Data source: Randomized controlled trial in 200 patients from 25 treatment centers in Japan,
Disclosures: The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.
Simultaneous resection reduced repeat intervention
ORLANDO – Combining surgical resection of primary carcinoid and neuroendocrine tumors with cytoreductive surgery of liver metastases is safe in select patients and can produce outcomes similar to those seen with surgery and adjuvant therapy, said investigators at the annual Digestive Disease Week.
Among 47 patients with carcinoid and neuroendocrine tumors (CNET), 22 of whom underwent simultaneous resection of primary tumors and surgical reduction of metastatic tumor burden with partial or near-total surgical cytoreduction (CR), and 25 of whom had resection of the primary with additional therapies, the 5-year survival rate was 82%, reported Dr. Nicholas N. Nissen of the Cedars-Sinai Medical Center in Los Angeles.
In addition, no patients who had near-total CR required a repeat hepatic intervention within 1 year of surgery, compared with 18 of 25 patients (72%) who had surgery followed by additional hepatic therapy, Dr. Nissen said.
"While most patients progress over time, overall survival is excellent, and we admit very freely that this reflects the growing and evolving multimodal therapies that are available to these patients," Dr. Nissen said.
"We would propose that simultaneous removal of the primary tumor and liver metastases may in fact be primarily beneficial as it consolidates procedures and allows some patients to delay or perhaps even avoid other locoregional hepatic therapies," he added.
The authors took a retrospective look at records of 51 patients, 47 of whom were available for the overall survival analysis. The patients all underwent resection of hepatic masses simultaneously with surgery to remove either small bowel carcinoid (32 patients) or pancreatic neuroendocrine tumor (15 patients). In all, 27 patients had partial surgical cytoreduction of metastases, and 22 had planned near-total surgical CR.
Of the 19 patients with carcinoid syndrome, all had what Dr. Nissen described as "dramatic improvement," and 11 had complete resolution of symptoms following surgery.
There were no deaths within 30 days of surgery. There were eight complications greater than Clavien grade 2, including two instances of bile leak requiring endoscopic retrograde cholangiopancreatography, and four cases requiring repeat laparotomy.
Overall survival for 47 patients with at least 5 years of data was 95% at 1 year, and 82% at years 3 and 5 of follow-up. Overall 5-year survival among those patients who had near-total CR was 88%, compared with 72% of those who had subtotal CR, but the difference was not statistically significant.
The respective progression-free survival rates were 77%, 37%, and 28%. Broken down by treatment type, 5-year PFS was 40% among patients who had near total CR, compared with 22% for those who had subtotal cytoreduction, but this difference was also not significant.
However, the seven patients who had no additional hepatic therapy had a more-than-threefold risk for progression, compared with either near total CR (hazard ratio [HR], 3.10; P = .044) or partial CR with additional liver treatment (HR, 3.37; P =.029).
No demographic or disease-related variables appeared to predict survival, but progression-free survival was significantly associated with poor differentiation (P = .022) and with large tumors (P = .044).
Dr. Carlos Corvera, a gastrointestinal surgeon at the University of California at San Francisco, who was not involved in the study, commented that the worse progression-free survival seen in the seven patients who did not receive adjuvant hepatic therapies suggested a benefit for additional cytoreduction, regardless of whether the patients are having symptoms.
"What do you tell your medical oncology colleagues who argue that disease-specific survival is really the most important thing, and that we end up predisposing these patients to possible [surgical] complications in situations where there’s really no significant survival benefit shown in asymptomatic patients?" he asked
Dr. Nissen replied that with the availability of new targeted systemic and locoregional therapies, in the near future the question may no longer when to operate and with what additional therapies, but "whether to operate."
The study sponsor was not disclosed. Dr. Nissen and Dr. Corvera reported having no relevant financial disclosures.
ORLANDO – Combining surgical resection of primary carcinoid and neuroendocrine tumors with cytoreductive surgery of liver metastases is safe in select patients and can produce outcomes similar to those seen with surgery and adjuvant therapy, said investigators at the annual Digestive Disease Week.
Among 47 patients with carcinoid and neuroendocrine tumors (CNET), 22 of whom underwent simultaneous resection of primary tumors and surgical reduction of metastatic tumor burden with partial or near-total surgical cytoreduction (CR), and 25 of whom had resection of the primary with additional therapies, the 5-year survival rate was 82%, reported Dr. Nicholas N. Nissen of the Cedars-Sinai Medical Center in Los Angeles.
In addition, no patients who had near-total CR required a repeat hepatic intervention within 1 year of surgery, compared with 18 of 25 patients (72%) who had surgery followed by additional hepatic therapy, Dr. Nissen said.
"While most patients progress over time, overall survival is excellent, and we admit very freely that this reflects the growing and evolving multimodal therapies that are available to these patients," Dr. Nissen said.
"We would propose that simultaneous removal of the primary tumor and liver metastases may in fact be primarily beneficial as it consolidates procedures and allows some patients to delay or perhaps even avoid other locoregional hepatic therapies," he added.
The authors took a retrospective look at records of 51 patients, 47 of whom were available for the overall survival analysis. The patients all underwent resection of hepatic masses simultaneously with surgery to remove either small bowel carcinoid (32 patients) or pancreatic neuroendocrine tumor (15 patients). In all, 27 patients had partial surgical cytoreduction of metastases, and 22 had planned near-total surgical CR.
Of the 19 patients with carcinoid syndrome, all had what Dr. Nissen described as "dramatic improvement," and 11 had complete resolution of symptoms following surgery.
There were no deaths within 30 days of surgery. There were eight complications greater than Clavien grade 2, including two instances of bile leak requiring endoscopic retrograde cholangiopancreatography, and four cases requiring repeat laparotomy.
Overall survival for 47 patients with at least 5 years of data was 95% at 1 year, and 82% at years 3 and 5 of follow-up. Overall 5-year survival among those patients who had near-total CR was 88%, compared with 72% of those who had subtotal CR, but the difference was not statistically significant.
The respective progression-free survival rates were 77%, 37%, and 28%. Broken down by treatment type, 5-year PFS was 40% among patients who had near total CR, compared with 22% for those who had subtotal cytoreduction, but this difference was also not significant.
However, the seven patients who had no additional hepatic therapy had a more-than-threefold risk for progression, compared with either near total CR (hazard ratio [HR], 3.10; P = .044) or partial CR with additional liver treatment (HR, 3.37; P =.029).
No demographic or disease-related variables appeared to predict survival, but progression-free survival was significantly associated with poor differentiation (P = .022) and with large tumors (P = .044).
Dr. Carlos Corvera, a gastrointestinal surgeon at the University of California at San Francisco, who was not involved in the study, commented that the worse progression-free survival seen in the seven patients who did not receive adjuvant hepatic therapies suggested a benefit for additional cytoreduction, regardless of whether the patients are having symptoms.
"What do you tell your medical oncology colleagues who argue that disease-specific survival is really the most important thing, and that we end up predisposing these patients to possible [surgical] complications in situations where there’s really no significant survival benefit shown in asymptomatic patients?" he asked
Dr. Nissen replied that with the availability of new targeted systemic and locoregional therapies, in the near future the question may no longer when to operate and with what additional therapies, but "whether to operate."
The study sponsor was not disclosed. Dr. Nissen and Dr. Corvera reported having no relevant financial disclosures.
ORLANDO – Combining surgical resection of primary carcinoid and neuroendocrine tumors with cytoreductive surgery of liver metastases is safe in select patients and can produce outcomes similar to those seen with surgery and adjuvant therapy, said investigators at the annual Digestive Disease Week.
Among 47 patients with carcinoid and neuroendocrine tumors (CNET), 22 of whom underwent simultaneous resection of primary tumors and surgical reduction of metastatic tumor burden with partial or near-total surgical cytoreduction (CR), and 25 of whom had resection of the primary with additional therapies, the 5-year survival rate was 82%, reported Dr. Nicholas N. Nissen of the Cedars-Sinai Medical Center in Los Angeles.
In addition, no patients who had near-total CR required a repeat hepatic intervention within 1 year of surgery, compared with 18 of 25 patients (72%) who had surgery followed by additional hepatic therapy, Dr. Nissen said.
"While most patients progress over time, overall survival is excellent, and we admit very freely that this reflects the growing and evolving multimodal therapies that are available to these patients," Dr. Nissen said.
"We would propose that simultaneous removal of the primary tumor and liver metastases may in fact be primarily beneficial as it consolidates procedures and allows some patients to delay or perhaps even avoid other locoregional hepatic therapies," he added.
The authors took a retrospective look at records of 51 patients, 47 of whom were available for the overall survival analysis. The patients all underwent resection of hepatic masses simultaneously with surgery to remove either small bowel carcinoid (32 patients) or pancreatic neuroendocrine tumor (15 patients). In all, 27 patients had partial surgical cytoreduction of metastases, and 22 had planned near-total surgical CR.
Of the 19 patients with carcinoid syndrome, all had what Dr. Nissen described as "dramatic improvement," and 11 had complete resolution of symptoms following surgery.
There were no deaths within 30 days of surgery. There were eight complications greater than Clavien grade 2, including two instances of bile leak requiring endoscopic retrograde cholangiopancreatography, and four cases requiring repeat laparotomy.
Overall survival for 47 patients with at least 5 years of data was 95% at 1 year, and 82% at years 3 and 5 of follow-up. Overall 5-year survival among those patients who had near-total CR was 88%, compared with 72% of those who had subtotal CR, but the difference was not statistically significant.
The respective progression-free survival rates were 77%, 37%, and 28%. Broken down by treatment type, 5-year PFS was 40% among patients who had near total CR, compared with 22% for those who had subtotal cytoreduction, but this difference was also not significant.
However, the seven patients who had no additional hepatic therapy had a more-than-threefold risk for progression, compared with either near total CR (hazard ratio [HR], 3.10; P = .044) or partial CR with additional liver treatment (HR, 3.37; P =.029).
No demographic or disease-related variables appeared to predict survival, but progression-free survival was significantly associated with poor differentiation (P = .022) and with large tumors (P = .044).
Dr. Carlos Corvera, a gastrointestinal surgeon at the University of California at San Francisco, who was not involved in the study, commented that the worse progression-free survival seen in the seven patients who did not receive adjuvant hepatic therapies suggested a benefit for additional cytoreduction, regardless of whether the patients are having symptoms.
"What do you tell your medical oncology colleagues who argue that disease-specific survival is really the most important thing, and that we end up predisposing these patients to possible [surgical] complications in situations where there’s really no significant survival benefit shown in asymptomatic patients?" he asked
Dr. Nissen replied that with the availability of new targeted systemic and locoregional therapies, in the near future the question may no longer when to operate and with what additional therapies, but "whether to operate."
The study sponsor was not disclosed. Dr. Nissen and Dr. Corvera reported having no relevant financial disclosures.
AT DDW 2013
Major finding: No patients who had surgical cytoreduction of liver metastases at the time or primary tumor resection required a repeat hepatic intervention within 1 year of surgery, compared with 18 of 25 patients (72%) who had surgery followed by additional hepatic therapy
Data source: Retrospective singe-institution case series.
Disclosures: The study sponsor was not disclosed. Dr. Nissen and Dr. Corvera reported having no relevant financial disclosures.
Nortriptyline no better than placebo for gastroparesis symptoms
ORLANDO – The tricyclic antidepressant nortriptyline is often prescribed for treatment of nausea, vomiting, and abdominal pain from gastroparesis, but results from a randomized clinical trial suggest that it doesn’t really work, investigators said at the annual Digestive Disease Week.
In a double-masked trial, 15 weeks of treatment with nortriptyline was no better than placebo for management of overall symptoms of idiopathic gastroparesis, reported Dr. Henry P. Parkman from Temple University in Philadelphia.
Although patients started on a 10-mg dose of nortriptyline had early improvement in nausea, this benefit disappeared as the dosage increased. In addition, 19 of the 65 patients assigned to the tricyclic antidepressant (TCA) opted to discontinue treatment early, primarily because of side effects, Dr. Parkman reported.
"Further studies will be needed to determine the role for TCAs and other neuromodulators in patients with idiopathic and also other etiologies of gastroparesis, and also to look at specific symptoms’ improvement associated with TCAs in gastroparesis," he said.
The investigators observed that the practice of treating idiopathic gastroparesis with TCAs is not well supported by clinical evidence, and took it on themselves to see whether they could gather sufficient evidence for or against the efficacy of these agents for this indication.
They chose nortriptyline because of its relatively low anticholinergic side effects, and used a dose-escalating scheme similar to that used in clinical practice.
They enrolled 130 patients into a placebo-controlled, parallel-group trial. Patients randomized to nortriptyline received it at a starting dose of 10 mg daily, which was escalated every 3 weeks to 25, 50, and finally 75 mg.
At the end of the 15 weeks, there were no significant differences between the groups in the primary endpoint, overall symptomatic improvement as measured by change in the 45-point, 9-symptom Gastroparesis Cardinal Symptom Index (GCSI). In all, 15 patients who received the TCA had at least a 50% decline from baseline GCSI score over two consecutive 3-week visits, compared with 14 patients on placebo.
Patients on nortriptyline did have a significant decline in both nausea (P = .04) and abdominal pain (P = .004) at the first visit, but this difference disappeared on subsequent visits.
At the end of the study, patients on the TCA also reported a greater improvement in appetite (P = .03), and showed a nonsignificant trend toward ability to finish a meal (P = .08). Patients on nortriptyline also had a slight gain in body mass index of 0.5 kg/m2, compared with a slight loss of –0.2 kg/m2 among patients on placebo (P = .03).
More than three times as many patients on nortriptyline stopped treatment early (19 vs. 6, P = .007), primarily because of side effects.
The investigators concluded that the role of TCAs and other neuromodulators for the treatment of idiopathic gastroparesis and other forms of gastrointestinal paralysis needs further exploration.
The study was funded by the National Institutes of Health. Dr. Parkman reported serving on advisory committees and review panels for Tranzyme, and consulting for Evoke, SmartPill, and other companies.
Gastroparesis (GP) is currently defined by a combination of symptoms (e.g., epigastric pain, nausea, vomiting, anorexia, bloating, and weight loss) and delayed gastric emptying in the absence of mechanical obstruction. The etiology of GP is diverse and includes diabetes, prior surgery, ischemia, connective tissue disorders, and vaccinations, although the largest group of GP patients is labeled as idiopathic.
Treatment of GP can be vexing for clinicians, as commonly used therapies (metoclopramide, erythromycin, and domperidone) are not uniformly effective, do not improve pain (one of the most common complaints in patients with GP), and are associated with side effects, some of which may be life-altering (i.e., tardive dyskinesia with metoclopramide). This has forced clinicians to search for alternative medications to treat GP symptoms.
Anecdotal reports have suggested that tricyclic antidepressants (TCAs) can improve symptoms in some patients with idiopathic GP. Theoretically, this appears to make sense, as TCAs improve visceral pain in patients with irritable bowel syndrome and functional abdominal pain. The prospective study by Parkman and colleagues was designed to evaluate the efficacy of nortriptyline in alleviating symptoms in patients with idiopathic GP. Frustratingly, nortriptyline was no better than placebo at improving global GP symptoms as measured by the Gastroparesis Cardinal Symptom Index.
These disappointing results may have occurred for a number of reasons, including the study being underpowered, the high dropout rate, too rapid dose escalation, use of a global scale, and not subtyping patients based on extent of pain or gastric emptying rates. These results should not dissuade clinicians from treating GP patients; rather, these results should serve as a stimulus to clinicians and researchers to identify an agent that can improve these chronic and debilitating symptoms.
Brian E. Lacy, M.D., Ph.D. is professor of medicine, section chief of gastroenterology and hepatology, and director of the GI Motility Laboratory at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H. He has no relevant financial disclosures.
Gastroparesis (GP) is currently defined by a combination of symptoms (e.g., epigastric pain, nausea, vomiting, anorexia, bloating, and weight loss) and delayed gastric emptying in the absence of mechanical obstruction. The etiology of GP is diverse and includes diabetes, prior surgery, ischemia, connective tissue disorders, and vaccinations, although the largest group of GP patients is labeled as idiopathic.
Treatment of GP can be vexing for clinicians, as commonly used therapies (metoclopramide, erythromycin, and domperidone) are not uniformly effective, do not improve pain (one of the most common complaints in patients with GP), and are associated with side effects, some of which may be life-altering (i.e., tardive dyskinesia with metoclopramide). This has forced clinicians to search for alternative medications to treat GP symptoms.
Anecdotal reports have suggested that tricyclic antidepressants (TCAs) can improve symptoms in some patients with idiopathic GP. Theoretically, this appears to make sense, as TCAs improve visceral pain in patients with irritable bowel syndrome and functional abdominal pain. The prospective study by Parkman and colleagues was designed to evaluate the efficacy of nortriptyline in alleviating symptoms in patients with idiopathic GP. Frustratingly, nortriptyline was no better than placebo at improving global GP symptoms as measured by the Gastroparesis Cardinal Symptom Index.
These disappointing results may have occurred for a number of reasons, including the study being underpowered, the high dropout rate, too rapid dose escalation, use of a global scale, and not subtyping patients based on extent of pain or gastric emptying rates. These results should not dissuade clinicians from treating GP patients; rather, these results should serve as a stimulus to clinicians and researchers to identify an agent that can improve these chronic and debilitating symptoms.
Brian E. Lacy, M.D., Ph.D. is professor of medicine, section chief of gastroenterology and hepatology, and director of the GI Motility Laboratory at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H. He has no relevant financial disclosures.
Gastroparesis (GP) is currently defined by a combination of symptoms (e.g., epigastric pain, nausea, vomiting, anorexia, bloating, and weight loss) and delayed gastric emptying in the absence of mechanical obstruction. The etiology of GP is diverse and includes diabetes, prior surgery, ischemia, connective tissue disorders, and vaccinations, although the largest group of GP patients is labeled as idiopathic.
Treatment of GP can be vexing for clinicians, as commonly used therapies (metoclopramide, erythromycin, and domperidone) are not uniformly effective, do not improve pain (one of the most common complaints in patients with GP), and are associated with side effects, some of which may be life-altering (i.e., tardive dyskinesia with metoclopramide). This has forced clinicians to search for alternative medications to treat GP symptoms.
Anecdotal reports have suggested that tricyclic antidepressants (TCAs) can improve symptoms in some patients with idiopathic GP. Theoretically, this appears to make sense, as TCAs improve visceral pain in patients with irritable bowel syndrome and functional abdominal pain. The prospective study by Parkman and colleagues was designed to evaluate the efficacy of nortriptyline in alleviating symptoms in patients with idiopathic GP. Frustratingly, nortriptyline was no better than placebo at improving global GP symptoms as measured by the Gastroparesis Cardinal Symptom Index.
These disappointing results may have occurred for a number of reasons, including the study being underpowered, the high dropout rate, too rapid dose escalation, use of a global scale, and not subtyping patients based on extent of pain or gastric emptying rates. These results should not dissuade clinicians from treating GP patients; rather, these results should serve as a stimulus to clinicians and researchers to identify an agent that can improve these chronic and debilitating symptoms.
Brian E. Lacy, M.D., Ph.D. is professor of medicine, section chief of gastroenterology and hepatology, and director of the GI Motility Laboratory at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H. He has no relevant financial disclosures.
ORLANDO – The tricyclic antidepressant nortriptyline is often prescribed for treatment of nausea, vomiting, and abdominal pain from gastroparesis, but results from a randomized clinical trial suggest that it doesn’t really work, investigators said at the annual Digestive Disease Week.
In a double-masked trial, 15 weeks of treatment with nortriptyline was no better than placebo for management of overall symptoms of idiopathic gastroparesis, reported Dr. Henry P. Parkman from Temple University in Philadelphia.
Although patients started on a 10-mg dose of nortriptyline had early improvement in nausea, this benefit disappeared as the dosage increased. In addition, 19 of the 65 patients assigned to the tricyclic antidepressant (TCA) opted to discontinue treatment early, primarily because of side effects, Dr. Parkman reported.
"Further studies will be needed to determine the role for TCAs and other neuromodulators in patients with idiopathic and also other etiologies of gastroparesis, and also to look at specific symptoms’ improvement associated with TCAs in gastroparesis," he said.
The investigators observed that the practice of treating idiopathic gastroparesis with TCAs is not well supported by clinical evidence, and took it on themselves to see whether they could gather sufficient evidence for or against the efficacy of these agents for this indication.
They chose nortriptyline because of its relatively low anticholinergic side effects, and used a dose-escalating scheme similar to that used in clinical practice.
They enrolled 130 patients into a placebo-controlled, parallel-group trial. Patients randomized to nortriptyline received it at a starting dose of 10 mg daily, which was escalated every 3 weeks to 25, 50, and finally 75 mg.
At the end of the 15 weeks, there were no significant differences between the groups in the primary endpoint, overall symptomatic improvement as measured by change in the 45-point, 9-symptom Gastroparesis Cardinal Symptom Index (GCSI). In all, 15 patients who received the TCA had at least a 50% decline from baseline GCSI score over two consecutive 3-week visits, compared with 14 patients on placebo.
Patients on nortriptyline did have a significant decline in both nausea (P = .04) and abdominal pain (P = .004) at the first visit, but this difference disappeared on subsequent visits.
At the end of the study, patients on the TCA also reported a greater improvement in appetite (P = .03), and showed a nonsignificant trend toward ability to finish a meal (P = .08). Patients on nortriptyline also had a slight gain in body mass index of 0.5 kg/m2, compared with a slight loss of –0.2 kg/m2 among patients on placebo (P = .03).
More than three times as many patients on nortriptyline stopped treatment early (19 vs. 6, P = .007), primarily because of side effects.
The investigators concluded that the role of TCAs and other neuromodulators for the treatment of idiopathic gastroparesis and other forms of gastrointestinal paralysis needs further exploration.
The study was funded by the National Institutes of Health. Dr. Parkman reported serving on advisory committees and review panels for Tranzyme, and consulting for Evoke, SmartPill, and other companies.
ORLANDO – The tricyclic antidepressant nortriptyline is often prescribed for treatment of nausea, vomiting, and abdominal pain from gastroparesis, but results from a randomized clinical trial suggest that it doesn’t really work, investigators said at the annual Digestive Disease Week.
In a double-masked trial, 15 weeks of treatment with nortriptyline was no better than placebo for management of overall symptoms of idiopathic gastroparesis, reported Dr. Henry P. Parkman from Temple University in Philadelphia.
Although patients started on a 10-mg dose of nortriptyline had early improvement in nausea, this benefit disappeared as the dosage increased. In addition, 19 of the 65 patients assigned to the tricyclic antidepressant (TCA) opted to discontinue treatment early, primarily because of side effects, Dr. Parkman reported.
"Further studies will be needed to determine the role for TCAs and other neuromodulators in patients with idiopathic and also other etiologies of gastroparesis, and also to look at specific symptoms’ improvement associated with TCAs in gastroparesis," he said.
The investigators observed that the practice of treating idiopathic gastroparesis with TCAs is not well supported by clinical evidence, and took it on themselves to see whether they could gather sufficient evidence for or against the efficacy of these agents for this indication.
They chose nortriptyline because of its relatively low anticholinergic side effects, and used a dose-escalating scheme similar to that used in clinical practice.
They enrolled 130 patients into a placebo-controlled, parallel-group trial. Patients randomized to nortriptyline received it at a starting dose of 10 mg daily, which was escalated every 3 weeks to 25, 50, and finally 75 mg.
At the end of the 15 weeks, there were no significant differences between the groups in the primary endpoint, overall symptomatic improvement as measured by change in the 45-point, 9-symptom Gastroparesis Cardinal Symptom Index (GCSI). In all, 15 patients who received the TCA had at least a 50% decline from baseline GCSI score over two consecutive 3-week visits, compared with 14 patients on placebo.
Patients on nortriptyline did have a significant decline in both nausea (P = .04) and abdominal pain (P = .004) at the first visit, but this difference disappeared on subsequent visits.
At the end of the study, patients on the TCA also reported a greater improvement in appetite (P = .03), and showed a nonsignificant trend toward ability to finish a meal (P = .08). Patients on nortriptyline also had a slight gain in body mass index of 0.5 kg/m2, compared with a slight loss of –0.2 kg/m2 among patients on placebo (P = .03).
More than three times as many patients on nortriptyline stopped treatment early (19 vs. 6, P = .007), primarily because of side effects.
The investigators concluded that the role of TCAs and other neuromodulators for the treatment of idiopathic gastroparesis and other forms of gastrointestinal paralysis needs further exploration.
The study was funded by the National Institutes of Health. Dr. Parkman reported serving on advisory committees and review panels for Tranzyme, and consulting for Evoke, SmartPill, and other companies.
AT DDW 2013
Major finding: There were no significant differences in improvement of gastroparesis symptom scores with nortriptyline vs. placebo.
Data source: Randomized, double-masked, placebo-controlled trial in 130 patients with gastroparesis.
Disclosures: The study was funded by the National Institutes of Health. Dr. Parkman reported serving on advisory committees and review panels for Tranzyme, and consulting for Evoke, SmartPill, and other companies.
Low vitamin D level may up risk for IBD flares
ORLANDO – Vitamin D may protect patients with inflammatory bowel disease from more serious disease flare-ups, investigators reported at the annual Digestive Disease Week.
Among 3,217 patients followed for a median of 8 years, those with Crohn’s disease who had the lowest levels of plasma 25-hydroxyvitamin D had a nearly twofold risk for surgery and double the risk for hospitalization related to IBD, compared with patients who had higher vitamin D levels.
A similar relationship was seen between vitamin D levels and risk of surgery and hospitalization among patients with ulcerative colitis (UC), reported Dr. Ashwin Ananthakrishnan of Massachusetts General Hospital in Boston.
Tellingly, patients with Crohn’s disease (CD) who had initially low vitamin D levels that normalized during the study had significant reductions in their risk of surgery and hospitalization compared with patients whose vitamin D levels did not improve over time. In addition, patients with both CD and UC who normalized their vitamin D status during the study had significantly lower levels of the inflammatory marker C-reactive protein, the investigators found.
"There’s considerable evidence that supports a role for vitamin D in inflammatory bowel diseases," Dr. Ananthakrishnan said.
He noted that high vitamin D levels were associated with a reduced risk for CD in a prior study performed by his group (Gastroenterology 2012;142:482-9), and a second study showed that polymorphisms in the vitamin D receptor were associated with a risk of both CD and UC (Gut 2000;47:211-4).
Although vitamin D levels have been weakly associated with IBD exacerbations in retrospective studies, stronger evidence for the potential anti-inflammatory role of vitamin D has been hard to come by, partly because of researchers’ inability to determine vitamin D status before clinical outcomes such as surgery or hospitalization, Dr. Ananthakrishnan said.
He and colleagues prospectively followed all members of an IBD cohort treated at Massachusetts General Hospital and Brigham and Women’s Hospital, Boston, who had a least one measured plasma 25(OH)D level before a first IBD-related surgery and/or hospitalization (the primary outcome; median C-reactive protein was a secondary outcome).
The researchers found that 16% of all patients had disease-related surgery, and 40% were hospitalized during the follow-up period.
A third of all patients (32%) were considered to be vitamin D deficient, defined as having a plasma 25(OH)D level below 20 ng/mL, and 28% were deemed to be vitamin D insufficient (20-30 ng/mL). The remaining 40% had sufficient vitamin D levels of 30 ng/mL and higher.
When the investigators controlled for age, sex, race, Charlson score (non-IBD comorbidity), disease-related complications, medication, vitamin D supplementation, and season of 25(OH)D measurement, analysis showed that patients with CD who had plasma vitamin D levels below 20 ng/mL had odds ratios of 1.76 for surgery and 2.07 for IBD-related hospitalization.
Similarly, for patients with UC and low vitamin D levels, the odds ratios for surgery and hospitalization were 1.70 and 2.26, respectively.
Overall, 76% of patients in the study with CD who had initial vitamin D levels below 30 ng/mL had subsequent normalization of their D values, as did 80% of those with ulcerative colitis.
In adjusted analysis, patients with CD had a nearly 50% reduction in the risk of surgery (odds ratio, 0.56) and a nearly 25% reduction in the risk of hospitalization (OR, 0.78), compared with patients whose vitamin D levels never corrected to the normal range. Patients with UC also had reductions in risk for both surgery and hospitalization, but these reductions were not significant.
In addition, patients with CD and UC who had vitamin D that normalized over the course of the study had significantly lower C-reactive protein levels than did those who remained vitamin D deficient (–5. 2 mg/L, P = .002).
The study was supported by grants and awards from the American Gastroenterological Association, the IBD Working Group, the Broad Foundation, and the National Institutes of Health. Dr. Ananthakrishnan reported having no financial disclosures.
ORLANDO – Vitamin D may protect patients with inflammatory bowel disease from more serious disease flare-ups, investigators reported at the annual Digestive Disease Week.
Among 3,217 patients followed for a median of 8 years, those with Crohn’s disease who had the lowest levels of plasma 25-hydroxyvitamin D had a nearly twofold risk for surgery and double the risk for hospitalization related to IBD, compared with patients who had higher vitamin D levels.
A similar relationship was seen between vitamin D levels and risk of surgery and hospitalization among patients with ulcerative colitis (UC), reported Dr. Ashwin Ananthakrishnan of Massachusetts General Hospital in Boston.
Tellingly, patients with Crohn’s disease (CD) who had initially low vitamin D levels that normalized during the study had significant reductions in their risk of surgery and hospitalization compared with patients whose vitamin D levels did not improve over time. In addition, patients with both CD and UC who normalized their vitamin D status during the study had significantly lower levels of the inflammatory marker C-reactive protein, the investigators found.
"There’s considerable evidence that supports a role for vitamin D in inflammatory bowel diseases," Dr. Ananthakrishnan said.
He noted that high vitamin D levels were associated with a reduced risk for CD in a prior study performed by his group (Gastroenterology 2012;142:482-9), and a second study showed that polymorphisms in the vitamin D receptor were associated with a risk of both CD and UC (Gut 2000;47:211-4).
Although vitamin D levels have been weakly associated with IBD exacerbations in retrospective studies, stronger evidence for the potential anti-inflammatory role of vitamin D has been hard to come by, partly because of researchers’ inability to determine vitamin D status before clinical outcomes such as surgery or hospitalization, Dr. Ananthakrishnan said.
He and colleagues prospectively followed all members of an IBD cohort treated at Massachusetts General Hospital and Brigham and Women’s Hospital, Boston, who had a least one measured plasma 25(OH)D level before a first IBD-related surgery and/or hospitalization (the primary outcome; median C-reactive protein was a secondary outcome).
The researchers found that 16% of all patients had disease-related surgery, and 40% were hospitalized during the follow-up period.
A third of all patients (32%) were considered to be vitamin D deficient, defined as having a plasma 25(OH)D level below 20 ng/mL, and 28% were deemed to be vitamin D insufficient (20-30 ng/mL). The remaining 40% had sufficient vitamin D levels of 30 ng/mL and higher.
When the investigators controlled for age, sex, race, Charlson score (non-IBD comorbidity), disease-related complications, medication, vitamin D supplementation, and season of 25(OH)D measurement, analysis showed that patients with CD who had plasma vitamin D levels below 20 ng/mL had odds ratios of 1.76 for surgery and 2.07 for IBD-related hospitalization.
Similarly, for patients with UC and low vitamin D levels, the odds ratios for surgery and hospitalization were 1.70 and 2.26, respectively.
Overall, 76% of patients in the study with CD who had initial vitamin D levels below 30 ng/mL had subsequent normalization of their D values, as did 80% of those with ulcerative colitis.
In adjusted analysis, patients with CD had a nearly 50% reduction in the risk of surgery (odds ratio, 0.56) and a nearly 25% reduction in the risk of hospitalization (OR, 0.78), compared with patients whose vitamin D levels never corrected to the normal range. Patients with UC also had reductions in risk for both surgery and hospitalization, but these reductions were not significant.
In addition, patients with CD and UC who had vitamin D that normalized over the course of the study had significantly lower C-reactive protein levels than did those who remained vitamin D deficient (–5. 2 mg/L, P = .002).
The study was supported by grants and awards from the American Gastroenterological Association, the IBD Working Group, the Broad Foundation, and the National Institutes of Health. Dr. Ananthakrishnan reported having no financial disclosures.
ORLANDO – Vitamin D may protect patients with inflammatory bowel disease from more serious disease flare-ups, investigators reported at the annual Digestive Disease Week.
Among 3,217 patients followed for a median of 8 years, those with Crohn’s disease who had the lowest levels of plasma 25-hydroxyvitamin D had a nearly twofold risk for surgery and double the risk for hospitalization related to IBD, compared with patients who had higher vitamin D levels.
A similar relationship was seen between vitamin D levels and risk of surgery and hospitalization among patients with ulcerative colitis (UC), reported Dr. Ashwin Ananthakrishnan of Massachusetts General Hospital in Boston.
Tellingly, patients with Crohn’s disease (CD) who had initially low vitamin D levels that normalized during the study had significant reductions in their risk of surgery and hospitalization compared with patients whose vitamin D levels did not improve over time. In addition, patients with both CD and UC who normalized their vitamin D status during the study had significantly lower levels of the inflammatory marker C-reactive protein, the investigators found.
"There’s considerable evidence that supports a role for vitamin D in inflammatory bowel diseases," Dr. Ananthakrishnan said.
He noted that high vitamin D levels were associated with a reduced risk for CD in a prior study performed by his group (Gastroenterology 2012;142:482-9), and a second study showed that polymorphisms in the vitamin D receptor were associated with a risk of both CD and UC (Gut 2000;47:211-4).
Although vitamin D levels have been weakly associated with IBD exacerbations in retrospective studies, stronger evidence for the potential anti-inflammatory role of vitamin D has been hard to come by, partly because of researchers’ inability to determine vitamin D status before clinical outcomes such as surgery or hospitalization, Dr. Ananthakrishnan said.
He and colleagues prospectively followed all members of an IBD cohort treated at Massachusetts General Hospital and Brigham and Women’s Hospital, Boston, who had a least one measured plasma 25(OH)D level before a first IBD-related surgery and/or hospitalization (the primary outcome; median C-reactive protein was a secondary outcome).
The researchers found that 16% of all patients had disease-related surgery, and 40% were hospitalized during the follow-up period.
A third of all patients (32%) were considered to be vitamin D deficient, defined as having a plasma 25(OH)D level below 20 ng/mL, and 28% were deemed to be vitamin D insufficient (20-30 ng/mL). The remaining 40% had sufficient vitamin D levels of 30 ng/mL and higher.
When the investigators controlled for age, sex, race, Charlson score (non-IBD comorbidity), disease-related complications, medication, vitamin D supplementation, and season of 25(OH)D measurement, analysis showed that patients with CD who had plasma vitamin D levels below 20 ng/mL had odds ratios of 1.76 for surgery and 2.07 for IBD-related hospitalization.
Similarly, for patients with UC and low vitamin D levels, the odds ratios for surgery and hospitalization were 1.70 and 2.26, respectively.
Overall, 76% of patients in the study with CD who had initial vitamin D levels below 30 ng/mL had subsequent normalization of their D values, as did 80% of those with ulcerative colitis.
In adjusted analysis, patients with CD had a nearly 50% reduction in the risk of surgery (odds ratio, 0.56) and a nearly 25% reduction in the risk of hospitalization (OR, 0.78), compared with patients whose vitamin D levels never corrected to the normal range. Patients with UC also had reductions in risk for both surgery and hospitalization, but these reductions were not significant.
In addition, patients with CD and UC who had vitamin D that normalized over the course of the study had significantly lower C-reactive protein levels than did those who remained vitamin D deficient (–5. 2 mg/L, P = .002).
The study was supported by grants and awards from the American Gastroenterological Association, the IBD Working Group, the Broad Foundation, and the National Institutes of Health. Dr. Ananthakrishnan reported having no financial disclosures.
AT DDW 2013
Major finding: In all, 32% of patients with Crohn’s disease who had plasma vitamin D below 20 ng/mL had IBD-related surgery, compared with 13% of those with normal vitamin D levels.
Data source: Prospective cohort study using electronic medical records of 3,217 patients with irritable bowel disease.
Disclosures: The study was supported by grants/awards from the American Gastroenterological Association, the IBD Working Group, the Broad Foundation, and the National Institutes of Health. Dr. Ananthakrishnan reported having no financial disclosures.
Metformin appears to be associated with reduced colorectal cancer risk
ORLANDO – Metformin may be associated with a reduced risk of colorectal cancer in patients with type 2 diabetes, according to a meta-analysis that included mostly observational studies.
Sulfonylurea and insulin were not associated with a reduced risk and showed a nonsignificant trend toward a higher risk for colorectal cancer (CRC). No association was noted between CRC and thiazolidinedione (TZD), Dr. Siddharth Singh reported at the annual Digestive Disease Week.
CRC incidence was reduced by 10% among patients who were on metformin (n = 10 studies; adjusted odds ratio [AOR], 0.90; 95% confidence interval, 0.82-0.99; P = .02). The results were stable when the analysis was restricted to high-quality observational studies (n = 7 studies; AOR, 0.88; 95% CI, 0.79-0.98).
CRC risk was higher in patients on a sulfonylurea (n = 8 studies; AOR 1.12; 95% CI 0.99-1.26; P = .07) or on insulin (n = 10 studies; AOR, 1.25; 95% CI, 0.91-1.71; P = 0.17). Neither result was statistically significant, however.
Dr. Singh said that the findings warrant prospective cohort studies or randomized controlled trials of the chemopreventive effect of metformin in adults with type 2 diabetes.
Diabetes is an established risk factor for colorectal cancer, and preclinical and observational studies have shown that antidiabetes drugs may affect CRC risk. The relative affect of various antidiabetes drugs on CRC risk is unclear, said Dr. Singh of the Mayo Clinic in Rochester, Minn.
Dr. Singh and his colleagues conducted a systematic review and meta-analysis of 15 studies evaluating the effects of metformin, TZDs, sulfonylureas, and insulin on colorectal cancer risk. There was considerable heterogeneity across the studies, which may be explained by study design, location, and whether the study accounted for the effects of other antidiabetic drugs, Dr. Singh said.
Five case-control studies, eight cohort studies, and two randomized controlled trials with a total of nearly 14,000 CRC cases in 841,000 diabetes patients were included in the meta-analysis.
TZD was not associated with CRC risk (n = 6 studies; AOR, 0.95; 95% CI, 0.87-1.03; P = .24).
One of the main limitations of the unpublished study was that the significant results were seen only in observational studies and not in post-hoc analysis of the randomized controlled trials. Also, there are residual confounding factors, including failure to adjust for obesity, and confounding by indication and severity of diabetes, Dr. Singh said.
"Before we take part in any proactive treatment regimen, we have to have well-designed, randomized controlled trials," said Dr. N. Jewel Samadder, assistant professor of medicine at the University of Utah, Salt Lake City. "However, the observational studies, and the meta-analysis that [follow], are certainly hypothesis driving. Diabetes itself is a risk factor [for CRC], and some of the medications may alter that risk," said Dr. Samadder, who was not involved in the study.
Dr. Singh had no disclosures. Dr. Samadder has received speaking and teaching honoraria from Cook.
On Twitter @NaseemSMiller
ORLANDO – Metformin may be associated with a reduced risk of colorectal cancer in patients with type 2 diabetes, according to a meta-analysis that included mostly observational studies.
Sulfonylurea and insulin were not associated with a reduced risk and showed a nonsignificant trend toward a higher risk for colorectal cancer (CRC). No association was noted between CRC and thiazolidinedione (TZD), Dr. Siddharth Singh reported at the annual Digestive Disease Week.
CRC incidence was reduced by 10% among patients who were on metformin (n = 10 studies; adjusted odds ratio [AOR], 0.90; 95% confidence interval, 0.82-0.99; P = .02). The results were stable when the analysis was restricted to high-quality observational studies (n = 7 studies; AOR, 0.88; 95% CI, 0.79-0.98).
CRC risk was higher in patients on a sulfonylurea (n = 8 studies; AOR 1.12; 95% CI 0.99-1.26; P = .07) or on insulin (n = 10 studies; AOR, 1.25; 95% CI, 0.91-1.71; P = 0.17). Neither result was statistically significant, however.
Dr. Singh said that the findings warrant prospective cohort studies or randomized controlled trials of the chemopreventive effect of metformin in adults with type 2 diabetes.
Diabetes is an established risk factor for colorectal cancer, and preclinical and observational studies have shown that antidiabetes drugs may affect CRC risk. The relative affect of various antidiabetes drugs on CRC risk is unclear, said Dr. Singh of the Mayo Clinic in Rochester, Minn.
Dr. Singh and his colleagues conducted a systematic review and meta-analysis of 15 studies evaluating the effects of metformin, TZDs, sulfonylureas, and insulin on colorectal cancer risk. There was considerable heterogeneity across the studies, which may be explained by study design, location, and whether the study accounted for the effects of other antidiabetic drugs, Dr. Singh said.
Five case-control studies, eight cohort studies, and two randomized controlled trials with a total of nearly 14,000 CRC cases in 841,000 diabetes patients were included in the meta-analysis.
TZD was not associated with CRC risk (n = 6 studies; AOR, 0.95; 95% CI, 0.87-1.03; P = .24).
One of the main limitations of the unpublished study was that the significant results were seen only in observational studies and not in post-hoc analysis of the randomized controlled trials. Also, there are residual confounding factors, including failure to adjust for obesity, and confounding by indication and severity of diabetes, Dr. Singh said.
"Before we take part in any proactive treatment regimen, we have to have well-designed, randomized controlled trials," said Dr. N. Jewel Samadder, assistant professor of medicine at the University of Utah, Salt Lake City. "However, the observational studies, and the meta-analysis that [follow], are certainly hypothesis driving. Diabetes itself is a risk factor [for CRC], and some of the medications may alter that risk," said Dr. Samadder, who was not involved in the study.
Dr. Singh had no disclosures. Dr. Samadder has received speaking and teaching honoraria from Cook.
On Twitter @NaseemSMiller
ORLANDO – Metformin may be associated with a reduced risk of colorectal cancer in patients with type 2 diabetes, according to a meta-analysis that included mostly observational studies.
Sulfonylurea and insulin were not associated with a reduced risk and showed a nonsignificant trend toward a higher risk for colorectal cancer (CRC). No association was noted between CRC and thiazolidinedione (TZD), Dr. Siddharth Singh reported at the annual Digestive Disease Week.
CRC incidence was reduced by 10% among patients who were on metformin (n = 10 studies; adjusted odds ratio [AOR], 0.90; 95% confidence interval, 0.82-0.99; P = .02). The results were stable when the analysis was restricted to high-quality observational studies (n = 7 studies; AOR, 0.88; 95% CI, 0.79-0.98).
CRC risk was higher in patients on a sulfonylurea (n = 8 studies; AOR 1.12; 95% CI 0.99-1.26; P = .07) or on insulin (n = 10 studies; AOR, 1.25; 95% CI, 0.91-1.71; P = 0.17). Neither result was statistically significant, however.
Dr. Singh said that the findings warrant prospective cohort studies or randomized controlled trials of the chemopreventive effect of metformin in adults with type 2 diabetes.
Diabetes is an established risk factor for colorectal cancer, and preclinical and observational studies have shown that antidiabetes drugs may affect CRC risk. The relative affect of various antidiabetes drugs on CRC risk is unclear, said Dr. Singh of the Mayo Clinic in Rochester, Minn.
Dr. Singh and his colleagues conducted a systematic review and meta-analysis of 15 studies evaluating the effects of metformin, TZDs, sulfonylureas, and insulin on colorectal cancer risk. There was considerable heterogeneity across the studies, which may be explained by study design, location, and whether the study accounted for the effects of other antidiabetic drugs, Dr. Singh said.
Five case-control studies, eight cohort studies, and two randomized controlled trials with a total of nearly 14,000 CRC cases in 841,000 diabetes patients were included in the meta-analysis.
TZD was not associated with CRC risk (n = 6 studies; AOR, 0.95; 95% CI, 0.87-1.03; P = .24).
One of the main limitations of the unpublished study was that the significant results were seen only in observational studies and not in post-hoc analysis of the randomized controlled trials. Also, there are residual confounding factors, including failure to adjust for obesity, and confounding by indication and severity of diabetes, Dr. Singh said.
"Before we take part in any proactive treatment regimen, we have to have well-designed, randomized controlled trials," said Dr. N. Jewel Samadder, assistant professor of medicine at the University of Utah, Salt Lake City. "However, the observational studies, and the meta-analysis that [follow], are certainly hypothesis driving. Diabetes itself is a risk factor [for CRC], and some of the medications may alter that risk," said Dr. Samadder, who was not involved in the study.
Dr. Singh had no disclosures. Dr. Samadder has received speaking and teaching honoraria from Cook.
On Twitter @NaseemSMiller
AT DDW 2013
Major finding: Colorectal caner incidence was reduced by 10% among patients who were on metformin (n = 10 studies; adjusted OR, 0.90; 95% CI, 0.82-0.99; P = .02).
Data source: Meta-analysis of five case-control studies, eight cohort studies, and two randomized controlled trials that included nearly 14,000 CRC cases in 841,000 diabetes patients.
Disclosures: Dr. Singh had no disclosures. Dr. Samadder has received speaking and teaching honoraria from Cook.
Barrett's recurrence more frequent in older, nonwhite patients
ORLANDO – Age, race, and extent of disease treated appear to predict which patients will have a recurrence of Barrett’s esophagus after apparently successful radiofrequency ablation, investigators reported at the annual Digestive Disease Week.
A review of registry data from 148 centers in the United States shows that patients who experience a recurrence of Barrett’s after radiofrequency ablation (RFA) are more likely to be older, to be nonwhite, and to have had larger areas of involvement treated and fewer treatment sessions than patients with no recurrence, said Dr. William J. Bulsiewicz, of the University of North Carolina in Chapel Hill.
"These risk factors may point out biological differences between the populations [with Barrett’s] and help us to better understand the process of regeneration of squamous epithelium," he said.
There were recurrences in 28% of 1,602 patients who had complete eradication of intestinal metaplasia with RFA for Barrett’s and had at least 2 years of follow-up during which at least two biopsies were performed. The median time to recurrence was 1.4 years. Additionally, 33 patients were retreated for a suspected recurrence despite a lack of histological confirmation.
Based on a bivariate analysis of characteristics, patients with recurrent disease were more likely to have a higher mean age (63 vs. 61 years, P less than .01), to be male (77% vs. 71%, P = .03), to have longer esophageal segments with disease involvement (mean 4.3 vs. 3.7 cm, P less than .01), and to have low-grade dysplasia or worse prior to treatment (54% vs. 45%, P less than. 01).
The researchers used these and other patient and treatment characteristics in a logistic regression model to see which factors, if any, could independently predict recurrence.
Significant independent predictors of recurrence included nonwhite race (odds ratio, 2.47), length of the tubular esophagus with Barrett’s esophagus (OR, 1.09 per centimeter), age (OR, 1.02 per year), and number of RFA sessions required to treat initial disease (OR, 0.90 per treatment session).
Risk of recurrence was not associated with sex, pretreatment dysplasias, previous endoscopic mucosal resection, or treatment setting (academic medical center vs. community setting), Dr. Bulsiewicz said.
The investigators suggested that future surveillance protocols include age, race, esophageal length of Barrett’s involvement, and number of treatment sessions.
The study was funded by Covidien, GI Solutions, and the National Institutes of Health. Dr. Bulsiewicz reported having no financial disclosures.
ORLANDO – Age, race, and extent of disease treated appear to predict which patients will have a recurrence of Barrett’s esophagus after apparently successful radiofrequency ablation, investigators reported at the annual Digestive Disease Week.
A review of registry data from 148 centers in the United States shows that patients who experience a recurrence of Barrett’s after radiofrequency ablation (RFA) are more likely to be older, to be nonwhite, and to have had larger areas of involvement treated and fewer treatment sessions than patients with no recurrence, said Dr. William J. Bulsiewicz, of the University of North Carolina in Chapel Hill.
"These risk factors may point out biological differences between the populations [with Barrett’s] and help us to better understand the process of regeneration of squamous epithelium," he said.
There were recurrences in 28% of 1,602 patients who had complete eradication of intestinal metaplasia with RFA for Barrett’s and had at least 2 years of follow-up during which at least two biopsies were performed. The median time to recurrence was 1.4 years. Additionally, 33 patients were retreated for a suspected recurrence despite a lack of histological confirmation.
Based on a bivariate analysis of characteristics, patients with recurrent disease were more likely to have a higher mean age (63 vs. 61 years, P less than .01), to be male (77% vs. 71%, P = .03), to have longer esophageal segments with disease involvement (mean 4.3 vs. 3.7 cm, P less than .01), and to have low-grade dysplasia or worse prior to treatment (54% vs. 45%, P less than. 01).
The researchers used these and other patient and treatment characteristics in a logistic regression model to see which factors, if any, could independently predict recurrence.
Significant independent predictors of recurrence included nonwhite race (odds ratio, 2.47), length of the tubular esophagus with Barrett’s esophagus (OR, 1.09 per centimeter), age (OR, 1.02 per year), and number of RFA sessions required to treat initial disease (OR, 0.90 per treatment session).
Risk of recurrence was not associated with sex, pretreatment dysplasias, previous endoscopic mucosal resection, or treatment setting (academic medical center vs. community setting), Dr. Bulsiewicz said.
The investigators suggested that future surveillance protocols include age, race, esophageal length of Barrett’s involvement, and number of treatment sessions.
The study was funded by Covidien, GI Solutions, and the National Institutes of Health. Dr. Bulsiewicz reported having no financial disclosures.
ORLANDO – Age, race, and extent of disease treated appear to predict which patients will have a recurrence of Barrett’s esophagus after apparently successful radiofrequency ablation, investigators reported at the annual Digestive Disease Week.
A review of registry data from 148 centers in the United States shows that patients who experience a recurrence of Barrett’s after radiofrequency ablation (RFA) are more likely to be older, to be nonwhite, and to have had larger areas of involvement treated and fewer treatment sessions than patients with no recurrence, said Dr. William J. Bulsiewicz, of the University of North Carolina in Chapel Hill.
"These risk factors may point out biological differences between the populations [with Barrett’s] and help us to better understand the process of regeneration of squamous epithelium," he said.
There were recurrences in 28% of 1,602 patients who had complete eradication of intestinal metaplasia with RFA for Barrett’s and had at least 2 years of follow-up during which at least two biopsies were performed. The median time to recurrence was 1.4 years. Additionally, 33 patients were retreated for a suspected recurrence despite a lack of histological confirmation.
Based on a bivariate analysis of characteristics, patients with recurrent disease were more likely to have a higher mean age (63 vs. 61 years, P less than .01), to be male (77% vs. 71%, P = .03), to have longer esophageal segments with disease involvement (mean 4.3 vs. 3.7 cm, P less than .01), and to have low-grade dysplasia or worse prior to treatment (54% vs. 45%, P less than. 01).
The researchers used these and other patient and treatment characteristics in a logistic regression model to see which factors, if any, could independently predict recurrence.
Significant independent predictors of recurrence included nonwhite race (odds ratio, 2.47), length of the tubular esophagus with Barrett’s esophagus (OR, 1.09 per centimeter), age (OR, 1.02 per year), and number of RFA sessions required to treat initial disease (OR, 0.90 per treatment session).
Risk of recurrence was not associated with sex, pretreatment dysplasias, previous endoscopic mucosal resection, or treatment setting (academic medical center vs. community setting), Dr. Bulsiewicz said.
The investigators suggested that future surveillance protocols include age, race, esophageal length of Barrett’s involvement, and number of treatment sessions.
The study was funded by Covidien, GI Solutions, and the National Institutes of Health. Dr. Bulsiewicz reported having no financial disclosures.
AT DDW 2013
Major finding: Significant independent predictors of recurrence included nonwhite race (OR, 2.47), length of the tubular esophagus with Barrett’s esophagus (OR, 1.09 per centimeter), age (OR, 1.02 per year), and number of RFA sessions required to treat initial disease (OR, 0.90 per treatment session).
Data source: Review of data on 1,602 patients who underwent radiofrequency ablation with complete eradication of intestinal metaplasia.
Disclosures: The study was funded by Covidien, GI Solutions, and the National Institutes of Health. Dr. Bulsiewicz reported having no financial disclosures.
Narrow-band imaging colonoscopy predicts histology of diminutive polyps
ORLANDO – Narrow-band imaging colonoscopy accurately predicts the histology of most diminutive polyps in the distal colon, according to findings from a multicenter prospective study.
Use of the technology, which has been promoted as a method for differentiating hypoplastic and adenomatous polyps, could reduce the costs associated with pathological examinations and polypectomy by 60% and 33%, respectively, Dr. Alessandro Repici reported at the annual Digestive Disease Week.
The findings suggest that narrow-band imaging colonoscopy allows high-confidence prediction of the histology of some polyps smaller than 5 mm and is ready for prime time, Dr. Repici said.
"According to our study, high-confidence narrow-band imaging characterization of polyps less than 5 mm was able to meet the criteria threshold for incorporating this kind of real-time histology analysis in clinical practice. This may result in significant reduction of costs in terms of reduction of polypectomy and pathology assessment, and we believe that, according to the present study, high-confidence narrow-band imaging prediction of diminutive polyps located in the distal colon appears ready to be incorporated in clinical practice," he said.
In 278 consecutive patients undergoing elective colonoscopy, a total of 574 polyps smaller than 10 mm, including 429 polyps smaller than 5 mm, were retrieved for histological analysis and were assigned a designation of high or low confidence; 60% of the diminutive polyps were adenomatous. Narrow-band imaging had a sensitivity of 90%, a specificity of 88%, a positive predictive value of 89%, a negative predictive value of 89% and an accuracy of 89% for high-confidence prediction of adenomatous histology in lesions smaller than 5 mm, said Dr. Repici of Istituto Clinico Humanitas, Milan.
Overall, narrow-band imaging had an 84% negative predictive value for diminutive polyps, but the negative predictive value was 92% for those in the distal colon. This met the 90% threshold established by the American Society for Gastrointestinal Endoscopy for adequacy, he said.
Furthermore, high-confidence characterization of polyps smaller than 5 mm predicted the correct surveillance interval in 92% and 99% of cases by American and European guidelines, respectively, he said.
On multivariate analysis, the only independent predictor of an incorrect characterization of polyp histology by narrow-band imaging was a low level of confidence (odds ratio, 3.8), Dr. Repici said.
Study subjects were adults with a mean age of 63 years who underwent elective colonoscopy between May 2011 and May 2012. More than half (58%) were men, and 22% had a family history of colorectal cancer. Participating endoscopists were required to pass a qualifying examination before the start of the study.
Dr. Repici has served on advisory committees or review panels for Boston Scientific and Almirall Prodesfarma, and has served as a consultant for Cosmo Technologies. He has received grant and/or research or other support from Ferring Pharmaceuticals, Olympus Europe, US Endoscopy, and Cook.
ORLANDO – Narrow-band imaging colonoscopy accurately predicts the histology of most diminutive polyps in the distal colon, according to findings from a multicenter prospective study.
Use of the technology, which has been promoted as a method for differentiating hypoplastic and adenomatous polyps, could reduce the costs associated with pathological examinations and polypectomy by 60% and 33%, respectively, Dr. Alessandro Repici reported at the annual Digestive Disease Week.
The findings suggest that narrow-band imaging colonoscopy allows high-confidence prediction of the histology of some polyps smaller than 5 mm and is ready for prime time, Dr. Repici said.
"According to our study, high-confidence narrow-band imaging characterization of polyps less than 5 mm was able to meet the criteria threshold for incorporating this kind of real-time histology analysis in clinical practice. This may result in significant reduction of costs in terms of reduction of polypectomy and pathology assessment, and we believe that, according to the present study, high-confidence narrow-band imaging prediction of diminutive polyps located in the distal colon appears ready to be incorporated in clinical practice," he said.
In 278 consecutive patients undergoing elective colonoscopy, a total of 574 polyps smaller than 10 mm, including 429 polyps smaller than 5 mm, were retrieved for histological analysis and were assigned a designation of high or low confidence; 60% of the diminutive polyps were adenomatous. Narrow-band imaging had a sensitivity of 90%, a specificity of 88%, a positive predictive value of 89%, a negative predictive value of 89% and an accuracy of 89% for high-confidence prediction of adenomatous histology in lesions smaller than 5 mm, said Dr. Repici of Istituto Clinico Humanitas, Milan.
Overall, narrow-band imaging had an 84% negative predictive value for diminutive polyps, but the negative predictive value was 92% for those in the distal colon. This met the 90% threshold established by the American Society for Gastrointestinal Endoscopy for adequacy, he said.
Furthermore, high-confidence characterization of polyps smaller than 5 mm predicted the correct surveillance interval in 92% and 99% of cases by American and European guidelines, respectively, he said.
On multivariate analysis, the only independent predictor of an incorrect characterization of polyp histology by narrow-band imaging was a low level of confidence (odds ratio, 3.8), Dr. Repici said.
Study subjects were adults with a mean age of 63 years who underwent elective colonoscopy between May 2011 and May 2012. More than half (58%) were men, and 22% had a family history of colorectal cancer. Participating endoscopists were required to pass a qualifying examination before the start of the study.
Dr. Repici has served on advisory committees or review panels for Boston Scientific and Almirall Prodesfarma, and has served as a consultant for Cosmo Technologies. He has received grant and/or research or other support from Ferring Pharmaceuticals, Olympus Europe, US Endoscopy, and Cook.
ORLANDO – Narrow-band imaging colonoscopy accurately predicts the histology of most diminutive polyps in the distal colon, according to findings from a multicenter prospective study.
Use of the technology, which has been promoted as a method for differentiating hypoplastic and adenomatous polyps, could reduce the costs associated with pathological examinations and polypectomy by 60% and 33%, respectively, Dr. Alessandro Repici reported at the annual Digestive Disease Week.
The findings suggest that narrow-band imaging colonoscopy allows high-confidence prediction of the histology of some polyps smaller than 5 mm and is ready for prime time, Dr. Repici said.
"According to our study, high-confidence narrow-band imaging characterization of polyps less than 5 mm was able to meet the criteria threshold for incorporating this kind of real-time histology analysis in clinical practice. This may result in significant reduction of costs in terms of reduction of polypectomy and pathology assessment, and we believe that, according to the present study, high-confidence narrow-band imaging prediction of diminutive polyps located in the distal colon appears ready to be incorporated in clinical practice," he said.
In 278 consecutive patients undergoing elective colonoscopy, a total of 574 polyps smaller than 10 mm, including 429 polyps smaller than 5 mm, were retrieved for histological analysis and were assigned a designation of high or low confidence; 60% of the diminutive polyps were adenomatous. Narrow-band imaging had a sensitivity of 90%, a specificity of 88%, a positive predictive value of 89%, a negative predictive value of 89% and an accuracy of 89% for high-confidence prediction of adenomatous histology in lesions smaller than 5 mm, said Dr. Repici of Istituto Clinico Humanitas, Milan.
Overall, narrow-band imaging had an 84% negative predictive value for diminutive polyps, but the negative predictive value was 92% for those in the distal colon. This met the 90% threshold established by the American Society for Gastrointestinal Endoscopy for adequacy, he said.
Furthermore, high-confidence characterization of polyps smaller than 5 mm predicted the correct surveillance interval in 92% and 99% of cases by American and European guidelines, respectively, he said.
On multivariate analysis, the only independent predictor of an incorrect characterization of polyp histology by narrow-band imaging was a low level of confidence (odds ratio, 3.8), Dr. Repici said.
Study subjects were adults with a mean age of 63 years who underwent elective colonoscopy between May 2011 and May 2012. More than half (58%) were men, and 22% had a family history of colorectal cancer. Participating endoscopists were required to pass a qualifying examination before the start of the study.
Dr. Repici has served on advisory committees or review panels for Boston Scientific and Almirall Prodesfarma, and has served as a consultant for Cosmo Technologies. He has received grant and/or research or other support from Ferring Pharmaceuticals, Olympus Europe, US Endoscopy, and Cook.
AT DDW 2013
Major finding: The negative predictive value of narrow-band imaging colonoscopy was 92% for polyps less than 5 mm in the distal colon.
Data source: A prospective multicenter study of 278 consecutive patients.
Disclosures: Dr. Repici has served on advisory committees or review panels for Boston Scientific and Almirall Prodesfarma and has served as a consultant for Cosmo Technologies. He has received grant and/or research or other support from Ferring Pharmaceuticals, Olympus Europe, US Endoscopy, and Cook.
Coffee protects against primary sclerosing cholangitis
Coffee consumption appears to protect against the development of primary sclerosing cholangitis, but not against the development of primary biliary cirrhosis, according to findings from a case-control study involving more than 1,300 subjects.
Average coffee consumption was 50 cups per month among 348 study subjects with primary sclerosing cholangitis (PSC), and those subjects spent an average of 50% of their life actively drinking coffee. Average coffee consumption among 456 healthy controls was 78 cups per month, and those subjects spent an average of 67% of their life actively drinking coffee, Dr. Craig Lammert reported during a press briefing held prior to the annual Digestive Disease Week where the findings will be presented.
The differences between the PSC patients and the controls were statistically significant after adjustment for age and sex, said Dr. Lammert of Mayo Clinic, Rochester, Minn.
The healthy controls and 530 subjects with primary biliary cirrhosis (PBC) did not differ significantly with respect to mean age when coffee drinking began, estimated lifetime cups of coffee per month, or percent of life spent actively drinking coffee.
Study subjects were adult patients with well-defined PBC and PSC, and healthy controls recruited between 2002 and 2013. All completed a questionnaire about their coffee drinking history and status.
The PBC patients and healthy controls differed in terms of sex (89% vs. 74% in the groups, respectively, were women), but were of similar age (66 years in both groups). The groups did not differ in terms of the percentages of current coffee drinkers and never coffee drinkers.
The PSC patient and healthy control groups differed significantly both in terms of sex composition and age (57 vs. 66 years, in the groups, respectively). Furthermore, 21% of PSC patients, compared with 13% of controls, reported never drinking coffee, and 67% of PSC patients, compared with 78% of controls, were current coffee drinkers. These differences were significant even after adjustment for age and sex.
Coffee consumption has been linked with numerous health benefits, including protective effects in the liver, but detailed evaluation of coffee use among patients with cholestatic liver disease has been lacking, according to Dr. Lammert.
These findings reveal an environmental effect divergence between PSC and PBC, which is interesting given that coffee was previously thought to be protective in advanced liver disease, said Dr. Larry Friedman, Digestive Disease Week Council chair and chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass.
"The key question to answer is, why is PBC different?" he asked, adding that PBC appears to be an "outlier that doesn’t follow the model or patterns reported to date."
Indeed, the findings are expected to spur new research into the environmental factors associated with complex liver disease, Dr. Lammert said.
As for whether patients with PSC should be encouraged to drink coffee, Dr. Lammert said the data are insufficient for making specific recommendations at this point.
"But I won’t discourage it by any means," he said.
This study was funded by grants from the National Institutes of Health and the American Liver Foundation. Dr. Lammert reported having no disclosures.
Coffee consumption appears to protect against the development of primary sclerosing cholangitis, but not against the development of primary biliary cirrhosis, according to findings from a case-control study involving more than 1,300 subjects.
Average coffee consumption was 50 cups per month among 348 study subjects with primary sclerosing cholangitis (PSC), and those subjects spent an average of 50% of their life actively drinking coffee. Average coffee consumption among 456 healthy controls was 78 cups per month, and those subjects spent an average of 67% of their life actively drinking coffee, Dr. Craig Lammert reported during a press briefing held prior to the annual Digestive Disease Week where the findings will be presented.
The differences between the PSC patients and the controls were statistically significant after adjustment for age and sex, said Dr. Lammert of Mayo Clinic, Rochester, Minn.
The healthy controls and 530 subjects with primary biliary cirrhosis (PBC) did not differ significantly with respect to mean age when coffee drinking began, estimated lifetime cups of coffee per month, or percent of life spent actively drinking coffee.
Study subjects were adult patients with well-defined PBC and PSC, and healthy controls recruited between 2002 and 2013. All completed a questionnaire about their coffee drinking history and status.
The PBC patients and healthy controls differed in terms of sex (89% vs. 74% in the groups, respectively, were women), but were of similar age (66 years in both groups). The groups did not differ in terms of the percentages of current coffee drinkers and never coffee drinkers.
The PSC patient and healthy control groups differed significantly both in terms of sex composition and age (57 vs. 66 years, in the groups, respectively). Furthermore, 21% of PSC patients, compared with 13% of controls, reported never drinking coffee, and 67% of PSC patients, compared with 78% of controls, were current coffee drinkers. These differences were significant even after adjustment for age and sex.
Coffee consumption has been linked with numerous health benefits, including protective effects in the liver, but detailed evaluation of coffee use among patients with cholestatic liver disease has been lacking, according to Dr. Lammert.
These findings reveal an environmental effect divergence between PSC and PBC, which is interesting given that coffee was previously thought to be protective in advanced liver disease, said Dr. Larry Friedman, Digestive Disease Week Council chair and chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass.
"The key question to answer is, why is PBC different?" he asked, adding that PBC appears to be an "outlier that doesn’t follow the model or patterns reported to date."
Indeed, the findings are expected to spur new research into the environmental factors associated with complex liver disease, Dr. Lammert said.
As for whether patients with PSC should be encouraged to drink coffee, Dr. Lammert said the data are insufficient for making specific recommendations at this point.
"But I won’t discourage it by any means," he said.
This study was funded by grants from the National Institutes of Health and the American Liver Foundation. Dr. Lammert reported having no disclosures.
Coffee consumption appears to protect against the development of primary sclerosing cholangitis, but not against the development of primary biliary cirrhosis, according to findings from a case-control study involving more than 1,300 subjects.
Average coffee consumption was 50 cups per month among 348 study subjects with primary sclerosing cholangitis (PSC), and those subjects spent an average of 50% of their life actively drinking coffee. Average coffee consumption among 456 healthy controls was 78 cups per month, and those subjects spent an average of 67% of their life actively drinking coffee, Dr. Craig Lammert reported during a press briefing held prior to the annual Digestive Disease Week where the findings will be presented.
The differences between the PSC patients and the controls were statistically significant after adjustment for age and sex, said Dr. Lammert of Mayo Clinic, Rochester, Minn.
The healthy controls and 530 subjects with primary biliary cirrhosis (PBC) did not differ significantly with respect to mean age when coffee drinking began, estimated lifetime cups of coffee per month, or percent of life spent actively drinking coffee.
Study subjects were adult patients with well-defined PBC and PSC, and healthy controls recruited between 2002 and 2013. All completed a questionnaire about their coffee drinking history and status.
The PBC patients and healthy controls differed in terms of sex (89% vs. 74% in the groups, respectively, were women), but were of similar age (66 years in both groups). The groups did not differ in terms of the percentages of current coffee drinkers and never coffee drinkers.
The PSC patient and healthy control groups differed significantly both in terms of sex composition and age (57 vs. 66 years, in the groups, respectively). Furthermore, 21% of PSC patients, compared with 13% of controls, reported never drinking coffee, and 67% of PSC patients, compared with 78% of controls, were current coffee drinkers. These differences were significant even after adjustment for age and sex.
Coffee consumption has been linked with numerous health benefits, including protective effects in the liver, but detailed evaluation of coffee use among patients with cholestatic liver disease has been lacking, according to Dr. Lammert.
These findings reveal an environmental effect divergence between PSC and PBC, which is interesting given that coffee was previously thought to be protective in advanced liver disease, said Dr. Larry Friedman, Digestive Disease Week Council chair and chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass.
"The key question to answer is, why is PBC different?" he asked, adding that PBC appears to be an "outlier that doesn’t follow the model or patterns reported to date."
Indeed, the findings are expected to spur new research into the environmental factors associated with complex liver disease, Dr. Lammert said.
As for whether patients with PSC should be encouraged to drink coffee, Dr. Lammert said the data are insufficient for making specific recommendations at this point.
"But I won’t discourage it by any means," he said.
This study was funded by grants from the National Institutes of Health and the American Liver Foundation. Dr. Lammert reported having no disclosures.
Major finding: Average coffee consumption was 50 vs. 78 cups per month, and percent of life actively drinking coffee was 50% vs. 67% in PSC cases vs. healthy controls, respectively.
Data source: A case-control study involving 1,334 subjects.
Disclosures: This study was funded by grants from the National Institutes of Health and the American Liver Foundation. Dr. Lammert reported having no disclosures.
