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Jeff Evans has been editor of Rheumatology News/MDedge Rheumatology and the EULAR Congress News since 2013. He started at Frontline Medical Communications in 2001 and was a reporter for 8 years before serving as editor of Clinical Neurology News and World Neurology, and briefly as editor of GI & Hepatology News. He graduated cum laude from Cornell University (New York) with a BA in biological sciences, concentrating in neurobiology and behavior.
New Capsule Detects Esophagitis, Barrett's
ORLANDO, FLA. — A new video capsule for imaging the esophagus appears to detect esophagitis and Barrett's esophagus just as well as traditional endoscopy in patients with chronic symptoms of gastroesophageal reflux disease, according to the results of a prospective, multicenter study.
The Food and Drug Administration approved Pillcam ESO for the detection of esophageal pathologies last October. The new device is similar to the M2A capsule (now called Pillcam SB) but has cameras on each end of the pill to capture a total of four frames per second. Both devices are manufactured by Given Imaging.
Pillcam ESO, which is meant to be an easy screening procedure for potential premalignant lesions, “is not meant to replace a traditional endoscope,” Rami Eliakim, M.D., explained at the annual meeting of the American College of Gastroenterology.
Use of the device for widespread screening may lead to an increase in the number of patients undergoing traditional endoscopy, he said, adding that many gastroenterologists regularly do endoscopic screening of patients with Barrett's esophagus who have chronic GERD symptoms.
Up to 10% of white male patients with chronic GERD may have Barrett's esophagus. Patients with Barrett's esophagus develop esophageal adenocarcinoma at a rate of 0·5% per year.
Recent studies have shown that screening 50-year-old men with chronic GERD symptoms for esophageal adenocarcinoma “is probably cost-effective,” said Dr. Eliakim of Rambam Medical Center, Haifa, Israel.
Following a 6-hour fast, 109 patients with a mean age of 51 years ingested Pillcam ESO in the supine position, then underwent traditional endoscopy 30 minutes later with 2·5-5 mg of IV midazolam (Versed). One patient could not swallow Pillcam, and images could not be viewed in two other patients. Individuals with dysphagia, Zenker's diverticulum, suspected intestinal obstruction, major abdominal surgery within the last 6 months, or cardiac pacemakers did not participate—nor did pregnant or breast-feeding women.
Of the 106 remaining patients, 61 had positive and 38 had negative findings on both traditional and capsule endoscopy. In five patients, traditional endoscopy made a positive finding when capsule endoscopy did not. Two patients had positive findings with capsule endoscopy when traditional endoscopy found nothing. Barrett's esophagus was not confirmed histologically in all patients who showed signs of the condition during capsule endoscopy.
Based on those results, Pillcam ESO had 92% sensitivity, 95% specificity, 97% positive predictive value, and 88% negative predictive value for detecting either Barrett's esophagus or esophagitis. Capsule endoscopy detected Barrett's esophagus with 97% sensitivity and 99% specificity. The sensitivity of Pillcam ESO reached 89% sensitivity and 99% specificity in patients with esophagitis, Dr Eliakim said.
ORLANDO, FLA. — A new video capsule for imaging the esophagus appears to detect esophagitis and Barrett's esophagus just as well as traditional endoscopy in patients with chronic symptoms of gastroesophageal reflux disease, according to the results of a prospective, multicenter study.
The Food and Drug Administration approved Pillcam ESO for the detection of esophageal pathologies last October. The new device is similar to the M2A capsule (now called Pillcam SB) but has cameras on each end of the pill to capture a total of four frames per second. Both devices are manufactured by Given Imaging.
Pillcam ESO, which is meant to be an easy screening procedure for potential premalignant lesions, “is not meant to replace a traditional endoscope,” Rami Eliakim, M.D., explained at the annual meeting of the American College of Gastroenterology.
Use of the device for widespread screening may lead to an increase in the number of patients undergoing traditional endoscopy, he said, adding that many gastroenterologists regularly do endoscopic screening of patients with Barrett's esophagus who have chronic GERD symptoms.
Up to 10% of white male patients with chronic GERD may have Barrett's esophagus. Patients with Barrett's esophagus develop esophageal adenocarcinoma at a rate of 0·5% per year.
Recent studies have shown that screening 50-year-old men with chronic GERD symptoms for esophageal adenocarcinoma “is probably cost-effective,” said Dr. Eliakim of Rambam Medical Center, Haifa, Israel.
Following a 6-hour fast, 109 patients with a mean age of 51 years ingested Pillcam ESO in the supine position, then underwent traditional endoscopy 30 minutes later with 2·5-5 mg of IV midazolam (Versed). One patient could not swallow Pillcam, and images could not be viewed in two other patients. Individuals with dysphagia, Zenker's diverticulum, suspected intestinal obstruction, major abdominal surgery within the last 6 months, or cardiac pacemakers did not participate—nor did pregnant or breast-feeding women.
Of the 106 remaining patients, 61 had positive and 38 had negative findings on both traditional and capsule endoscopy. In five patients, traditional endoscopy made a positive finding when capsule endoscopy did not. Two patients had positive findings with capsule endoscopy when traditional endoscopy found nothing. Barrett's esophagus was not confirmed histologically in all patients who showed signs of the condition during capsule endoscopy.
Based on those results, Pillcam ESO had 92% sensitivity, 95% specificity, 97% positive predictive value, and 88% negative predictive value for detecting either Barrett's esophagus or esophagitis. Capsule endoscopy detected Barrett's esophagus with 97% sensitivity and 99% specificity. The sensitivity of Pillcam ESO reached 89% sensitivity and 99% specificity in patients with esophagitis, Dr Eliakim said.
ORLANDO, FLA. — A new video capsule for imaging the esophagus appears to detect esophagitis and Barrett's esophagus just as well as traditional endoscopy in patients with chronic symptoms of gastroesophageal reflux disease, according to the results of a prospective, multicenter study.
The Food and Drug Administration approved Pillcam ESO for the detection of esophageal pathologies last October. The new device is similar to the M2A capsule (now called Pillcam SB) but has cameras on each end of the pill to capture a total of four frames per second. Both devices are manufactured by Given Imaging.
Pillcam ESO, which is meant to be an easy screening procedure for potential premalignant lesions, “is not meant to replace a traditional endoscope,” Rami Eliakim, M.D., explained at the annual meeting of the American College of Gastroenterology.
Use of the device for widespread screening may lead to an increase in the number of patients undergoing traditional endoscopy, he said, adding that many gastroenterologists regularly do endoscopic screening of patients with Barrett's esophagus who have chronic GERD symptoms.
Up to 10% of white male patients with chronic GERD may have Barrett's esophagus. Patients with Barrett's esophagus develop esophageal adenocarcinoma at a rate of 0·5% per year.
Recent studies have shown that screening 50-year-old men with chronic GERD symptoms for esophageal adenocarcinoma “is probably cost-effective,” said Dr. Eliakim of Rambam Medical Center, Haifa, Israel.
Following a 6-hour fast, 109 patients with a mean age of 51 years ingested Pillcam ESO in the supine position, then underwent traditional endoscopy 30 minutes later with 2·5-5 mg of IV midazolam (Versed). One patient could not swallow Pillcam, and images could not be viewed in two other patients. Individuals with dysphagia, Zenker's diverticulum, suspected intestinal obstruction, major abdominal surgery within the last 6 months, or cardiac pacemakers did not participate—nor did pregnant or breast-feeding women.
Of the 106 remaining patients, 61 had positive and 38 had negative findings on both traditional and capsule endoscopy. In five patients, traditional endoscopy made a positive finding when capsule endoscopy did not. Two patients had positive findings with capsule endoscopy when traditional endoscopy found nothing. Barrett's esophagus was not confirmed histologically in all patients who showed signs of the condition during capsule endoscopy.
Based on those results, Pillcam ESO had 92% sensitivity, 95% specificity, 97% positive predictive value, and 88% negative predictive value for detecting either Barrett's esophagus or esophagitis. Capsule endoscopy detected Barrett's esophagus with 97% sensitivity and 99% specificity. The sensitivity of Pillcam ESO reached 89% sensitivity and 99% specificity in patients with esophagitis, Dr Eliakim said.
Clinical Capsules
ALT Levels in Hepatitis C
Patients with chronic hepatitis C who have normal alanine aminotransferase levels should be treated with the standard of care—peginterferon alfa-2a and ribavirin—that is given to patients with elevated ALT levels, said Stefan Zeuzem, M.D., of Saarland University Hospital, Homburg/Saar, Germany, and his associates.
The combination of peginterferon alfa-2a plus ribavirin produced a sustained virologic response (SVR) in 30% of 212 patients who were treated for 24 weeks and in 52% of 210 patients who were treated for 48 weeks, compared with none of 69 patients who did not receive any treatment in a randomized, open-label trial. The rate of SVR in patients treated for 48 weeks is comparable with the SVR rates of 54%-63% reported in patients with elevated ALT levels treated with the same regimen (Gastroenterology 2004;127:1724-32).
The median ALT activity declined up to 10 U/L in treated patients and remained low in sustained responders in the trial, which was funded by Roche, the marketer of peginterferon alfa-2a (Pegasys) and ribavirin (Copegus). The ALT activity of 52% of control patients increased at some point during the study, which “supports the concept that, in many patients, the persistence of the ALT activity within normal levels is a function of monitoring frequency,” the investigators said.
Briefer Treatment for Hepatitis C?
Patients infected with hepatitis C virus genotypes 2 or 3 who achieve an early virologic response to peginterferon alfa-2b and ribavirin have a high rate of sustained virologic response after only 14 weeks of treatment, reported Olav Dalgard, M.D., of Aker University Hospital, Oslo, and his associates.
In a nonrandomized pilot study, 85 of 95 patients with an early virologic response (EVR) after 4 weeks of treatment sustained the response after 14 weeks, compared with 15 of 27 patients who did not have an EVR but had a sustained virologic response (SVR) after 24 weeks. The patients had a median age of 37 years, a body mass index of 25 kg/m2, and most had no or minimal fibrosis.
The absence of bridging fibrosis or cirrhosis was the only independent predictor of SVR or EVR in patients who had biopsies. In patients with or without a biopsy, independent predictors of SVR were age less than 40 years, receipt of both drugs 80% or more of the planned time, viral load less than 600,000 U/mL, and being negative for hepatitis C viral RNA at week 4. The two groups had similar rates of adverse events (Hepatology 2004;40:1260-5).
“Short-term treatment should probably be restricted to patients infected with genotype 2 or 3 who do not exhibit bridging fibrosis or cirrhosis,” the investigators said, but “the results need to be confirmed in a randomized, controlled study.”
Serum Markers Detect Liver Fibrosis
A new algorithm can distinguish between patients with little or no liver fibrosis and those with clinically significant fibrosis.
William M.C. Rosenberg of the University of Southampton (England) and his colleagues developed the algorithm, which uses serum markers that represent the constituents of matrix and enzymes involved in fibrosis and fibrolysis. The algorithm excluded significant fibrosis with a sensitivity greater than 90% and detected significant fibrosis with a specificity greater than 90%. The algorithm combines patient age with levels of the serum markers hyaluronic acid, N-terminal propeptide of type III collagen, and tissue inhibitor of matrix metalloproteinase 1 (Gastroenterology 2004;127:1704-13).
This diagnostic accuracy “appears to be similar to that of the previously published tests, that is, best for the extreme ends of the fibrosis spectrum,” D. Montgomery Bissell, M.D., of the University of California, San Francisco, said in an editorial (Gastroenterology 2004;127:1847-9).
GERD in Asthmatic Adults
One-third of adult patients with asthma have gastroesophageal reflux disease, but many do not have typical reflux symptoms or acidic reflux, reported Toni O. Kiljander, M.D., and Jukka O. Laitinen, M.D., of Tampere (Finland) University Hospital.
In 90 randomly selected patients with asthma and an average age of 54 years, 36% had abnormal acidic reflux in the distal esophagus during 24-hour esophageal pH monitoring; 25% of the patients with abnormal acidic reflux did not have typical symptoms of gastroesophageal reflux disease (GERD). Of the 47 patients who presented with typical GERD symptoms, 51% had GERD according to pH monitoring (Chest 2004;126:1490-4).
“We do not know which asthmatic patients would benefit from GER therapy,” Susan M. Harding, M.D., of the University of Alabama at Birmingham, said in an editorial (Chest 2004;126:1398-9).
ALT Levels in Hepatitis C
Patients with chronic hepatitis C who have normal alanine aminotransferase levels should be treated with the standard of care—peginterferon alfa-2a and ribavirin—that is given to patients with elevated ALT levels, said Stefan Zeuzem, M.D., of Saarland University Hospital, Homburg/Saar, Germany, and his associates.
The combination of peginterferon alfa-2a plus ribavirin produced a sustained virologic response (SVR) in 30% of 212 patients who were treated for 24 weeks and in 52% of 210 patients who were treated for 48 weeks, compared with none of 69 patients who did not receive any treatment in a randomized, open-label trial. The rate of SVR in patients treated for 48 weeks is comparable with the SVR rates of 54%-63% reported in patients with elevated ALT levels treated with the same regimen (Gastroenterology 2004;127:1724-32).
The median ALT activity declined up to 10 U/L in treated patients and remained low in sustained responders in the trial, which was funded by Roche, the marketer of peginterferon alfa-2a (Pegasys) and ribavirin (Copegus). The ALT activity of 52% of control patients increased at some point during the study, which “supports the concept that, in many patients, the persistence of the ALT activity within normal levels is a function of monitoring frequency,” the investigators said.
Briefer Treatment for Hepatitis C?
Patients infected with hepatitis C virus genotypes 2 or 3 who achieve an early virologic response to peginterferon alfa-2b and ribavirin have a high rate of sustained virologic response after only 14 weeks of treatment, reported Olav Dalgard, M.D., of Aker University Hospital, Oslo, and his associates.
In a nonrandomized pilot study, 85 of 95 patients with an early virologic response (EVR) after 4 weeks of treatment sustained the response after 14 weeks, compared with 15 of 27 patients who did not have an EVR but had a sustained virologic response (SVR) after 24 weeks. The patients had a median age of 37 years, a body mass index of 25 kg/m2, and most had no or minimal fibrosis.
The absence of bridging fibrosis or cirrhosis was the only independent predictor of SVR or EVR in patients who had biopsies. In patients with or without a biopsy, independent predictors of SVR were age less than 40 years, receipt of both drugs 80% or more of the planned time, viral load less than 600,000 U/mL, and being negative for hepatitis C viral RNA at week 4. The two groups had similar rates of adverse events (Hepatology 2004;40:1260-5).
“Short-term treatment should probably be restricted to patients infected with genotype 2 or 3 who do not exhibit bridging fibrosis or cirrhosis,” the investigators said, but “the results need to be confirmed in a randomized, controlled study.”
Serum Markers Detect Liver Fibrosis
A new algorithm can distinguish between patients with little or no liver fibrosis and those with clinically significant fibrosis.
William M.C. Rosenberg of the University of Southampton (England) and his colleagues developed the algorithm, which uses serum markers that represent the constituents of matrix and enzymes involved in fibrosis and fibrolysis. The algorithm excluded significant fibrosis with a sensitivity greater than 90% and detected significant fibrosis with a specificity greater than 90%. The algorithm combines patient age with levels of the serum markers hyaluronic acid, N-terminal propeptide of type III collagen, and tissue inhibitor of matrix metalloproteinase 1 (Gastroenterology 2004;127:1704-13).
This diagnostic accuracy “appears to be similar to that of the previously published tests, that is, best for the extreme ends of the fibrosis spectrum,” D. Montgomery Bissell, M.D., of the University of California, San Francisco, said in an editorial (Gastroenterology 2004;127:1847-9).
GERD in Asthmatic Adults
One-third of adult patients with asthma have gastroesophageal reflux disease, but many do not have typical reflux symptoms or acidic reflux, reported Toni O. Kiljander, M.D., and Jukka O. Laitinen, M.D., of Tampere (Finland) University Hospital.
In 90 randomly selected patients with asthma and an average age of 54 years, 36% had abnormal acidic reflux in the distal esophagus during 24-hour esophageal pH monitoring; 25% of the patients with abnormal acidic reflux did not have typical symptoms of gastroesophageal reflux disease (GERD). Of the 47 patients who presented with typical GERD symptoms, 51% had GERD according to pH monitoring (Chest 2004;126:1490-4).
“We do not know which asthmatic patients would benefit from GER therapy,” Susan M. Harding, M.D., of the University of Alabama at Birmingham, said in an editorial (Chest 2004;126:1398-9).
ALT Levels in Hepatitis C
Patients with chronic hepatitis C who have normal alanine aminotransferase levels should be treated with the standard of care—peginterferon alfa-2a and ribavirin—that is given to patients with elevated ALT levels, said Stefan Zeuzem, M.D., of Saarland University Hospital, Homburg/Saar, Germany, and his associates.
The combination of peginterferon alfa-2a plus ribavirin produced a sustained virologic response (SVR) in 30% of 212 patients who were treated for 24 weeks and in 52% of 210 patients who were treated for 48 weeks, compared with none of 69 patients who did not receive any treatment in a randomized, open-label trial. The rate of SVR in patients treated for 48 weeks is comparable with the SVR rates of 54%-63% reported in patients with elevated ALT levels treated with the same regimen (Gastroenterology 2004;127:1724-32).
The median ALT activity declined up to 10 U/L in treated patients and remained low in sustained responders in the trial, which was funded by Roche, the marketer of peginterferon alfa-2a (Pegasys) and ribavirin (Copegus). The ALT activity of 52% of control patients increased at some point during the study, which “supports the concept that, in many patients, the persistence of the ALT activity within normal levels is a function of monitoring frequency,” the investigators said.
Briefer Treatment for Hepatitis C?
Patients infected with hepatitis C virus genotypes 2 or 3 who achieve an early virologic response to peginterferon alfa-2b and ribavirin have a high rate of sustained virologic response after only 14 weeks of treatment, reported Olav Dalgard, M.D., of Aker University Hospital, Oslo, and his associates.
In a nonrandomized pilot study, 85 of 95 patients with an early virologic response (EVR) after 4 weeks of treatment sustained the response after 14 weeks, compared with 15 of 27 patients who did not have an EVR but had a sustained virologic response (SVR) after 24 weeks. The patients had a median age of 37 years, a body mass index of 25 kg/m2, and most had no or minimal fibrosis.
The absence of bridging fibrosis or cirrhosis was the only independent predictor of SVR or EVR in patients who had biopsies. In patients with or without a biopsy, independent predictors of SVR were age less than 40 years, receipt of both drugs 80% or more of the planned time, viral load less than 600,000 U/mL, and being negative for hepatitis C viral RNA at week 4. The two groups had similar rates of adverse events (Hepatology 2004;40:1260-5).
“Short-term treatment should probably be restricted to patients infected with genotype 2 or 3 who do not exhibit bridging fibrosis or cirrhosis,” the investigators said, but “the results need to be confirmed in a randomized, controlled study.”
Serum Markers Detect Liver Fibrosis
A new algorithm can distinguish between patients with little or no liver fibrosis and those with clinically significant fibrosis.
William M.C. Rosenberg of the University of Southampton (England) and his colleagues developed the algorithm, which uses serum markers that represent the constituents of matrix and enzymes involved in fibrosis and fibrolysis. The algorithm excluded significant fibrosis with a sensitivity greater than 90% and detected significant fibrosis with a specificity greater than 90%. The algorithm combines patient age with levels of the serum markers hyaluronic acid, N-terminal propeptide of type III collagen, and tissue inhibitor of matrix metalloproteinase 1 (Gastroenterology 2004;127:1704-13).
This diagnostic accuracy “appears to be similar to that of the previously published tests, that is, best for the extreme ends of the fibrosis spectrum,” D. Montgomery Bissell, M.D., of the University of California, San Francisco, said in an editorial (Gastroenterology 2004;127:1847-9).
GERD in Asthmatic Adults
One-third of adult patients with asthma have gastroesophageal reflux disease, but many do not have typical reflux symptoms or acidic reflux, reported Toni O. Kiljander, M.D., and Jukka O. Laitinen, M.D., of Tampere (Finland) University Hospital.
In 90 randomly selected patients with asthma and an average age of 54 years, 36% had abnormal acidic reflux in the distal esophagus during 24-hour esophageal pH monitoring; 25% of the patients with abnormal acidic reflux did not have typical symptoms of gastroesophageal reflux disease (GERD). Of the 47 patients who presented with typical GERD symptoms, 51% had GERD according to pH monitoring (Chest 2004;126:1490-4).
“We do not know which asthmatic patients would benefit from GER therapy,” Susan M. Harding, M.D., of the University of Alabama at Birmingham, said in an editorial (Chest 2004;126:1398-9).
MII-pH Measure Tags Cause of Recalcitrant Reflux
ORLANDO, FLA. — A new diagnostic tool that can detect reflux regardless of pH may help clinicians offer individualized treatment for gastroesophageal reflux disease, Inder Mainie, M.D., said at the annual meeting of the American College of Gastroenterology.
Used in conjunction with esophageal pH monitoring, multichannel intraluminal impedance (MII) monitoring can show whether symptoms of gastroesophageal reflux disease (GERD) are associated with acid or nonacid reflux events—or with no reflux at all, said Dr. Mainie of the digestive disease center at the Medical University of South Carolina, Charleston.
About 35% or more of patients with GERD have persistent reflux symptoms while on proton-pump inhibitor (PPI) therapy, Dr. Mainie noted.
Esophageal pH monitoring alone cannot detect reflux episodes that occur at a pH level of 4 or higher (nonacid reflux). But MII devices can detect gastroesophageal reflux independent of pH level based on the changes in the electrical conductivity in the lumen of the esophagus.
A combined approach that uses MII plus pH detection “brings a change in the paradigm for reflux detection,” Dr. Mainie said. “The impedance information identifies reflux episodes, while the pH electrode is used simply to categorize them as acid or nonacid.”
In 125 patients (average age 43 years) who had symptoms of GERD and who took PPIs twice per day, Dr. Mainie and his colleagues simultaneously measured acid and nonacid reflux at 3, 5, 7, 9, 15, and 17 cm above the lower esophageal sphincter with a combined MII-pH device that has been approved by the Food and Drug Administration.
Overall, 101 of the patients had reflux symptoms on the day of the testing. Each patient had nonacid reflux events. Typical GERD symptoms (heartburn, regurgitation, and chest pain) occurred in 58 of the patients.
Among these patients, a positive symptom index occurred with nonacid reflux in 45% and with acid reflux in 10%. Another 45% of patients had typical symptoms without reflux.
The symptom index (SI) represents the percentage of perceived gastroesophageal reflux-related symptoms that correlate with esophageal acid (or nonacid) reflux events. An SI score is positive if 50% or more of the perceived gastroesophageal reflux-related symptoms correlate with acid (or nonacid) reflux events.
In 43 patients who showed atypical GERD symptoms (abdominal discomfort, belch, catarrh, dysphagia, choking, globus, hoarseness, cough, wheeze, or acid taste), a positive SI occurred with nonacid reflux in 23% and with acid reflux in 2% of the patients. Reflux did not occur in 75% of patients who had atypical symptoms.
A positive SI was associated with nonacid reflux in 36% of all patients who experienced GERD-related symptoms during the study; 7% of patients with GERD-related symptoms had a positive SI for acid reflux. In contrast, 58% of patients had no reflux associated with their symptoms.
The percentage of patients with typical symptoms associated with reflux (55%) was significantly higher than the percentage of patients with atypical symptoms associated with reflux (25%).
A total of 15 of the symptomatic patients were younger than 16 years. No differences occurred in the types of reflux associated with symptoms between children or adults.
“MII-pH helps to clarify underlying, persistent GERD-related symptoms during PPI therapy,” Dr. Mainie said. “Clinical presentation alone is not sufficient to identify the presence or absence of reflux-causing symptoms.”
Dr. Mainie and his colleagues at the university are gathering data on the outcomes of these patients to determine the role of MII-pH in directing therapy.
ORLANDO, FLA. — A new diagnostic tool that can detect reflux regardless of pH may help clinicians offer individualized treatment for gastroesophageal reflux disease, Inder Mainie, M.D., said at the annual meeting of the American College of Gastroenterology.
Used in conjunction with esophageal pH monitoring, multichannel intraluminal impedance (MII) monitoring can show whether symptoms of gastroesophageal reflux disease (GERD) are associated with acid or nonacid reflux events—or with no reflux at all, said Dr. Mainie of the digestive disease center at the Medical University of South Carolina, Charleston.
About 35% or more of patients with GERD have persistent reflux symptoms while on proton-pump inhibitor (PPI) therapy, Dr. Mainie noted.
Esophageal pH monitoring alone cannot detect reflux episodes that occur at a pH level of 4 or higher (nonacid reflux). But MII devices can detect gastroesophageal reflux independent of pH level based on the changes in the electrical conductivity in the lumen of the esophagus.
A combined approach that uses MII plus pH detection “brings a change in the paradigm for reflux detection,” Dr. Mainie said. “The impedance information identifies reflux episodes, while the pH electrode is used simply to categorize them as acid or nonacid.”
In 125 patients (average age 43 years) who had symptoms of GERD and who took PPIs twice per day, Dr. Mainie and his colleagues simultaneously measured acid and nonacid reflux at 3, 5, 7, 9, 15, and 17 cm above the lower esophageal sphincter with a combined MII-pH device that has been approved by the Food and Drug Administration.
Overall, 101 of the patients had reflux symptoms on the day of the testing. Each patient had nonacid reflux events. Typical GERD symptoms (heartburn, regurgitation, and chest pain) occurred in 58 of the patients.
Among these patients, a positive symptom index occurred with nonacid reflux in 45% and with acid reflux in 10%. Another 45% of patients had typical symptoms without reflux.
The symptom index (SI) represents the percentage of perceived gastroesophageal reflux-related symptoms that correlate with esophageal acid (or nonacid) reflux events. An SI score is positive if 50% or more of the perceived gastroesophageal reflux-related symptoms correlate with acid (or nonacid) reflux events.
In 43 patients who showed atypical GERD symptoms (abdominal discomfort, belch, catarrh, dysphagia, choking, globus, hoarseness, cough, wheeze, or acid taste), a positive SI occurred with nonacid reflux in 23% and with acid reflux in 2% of the patients. Reflux did not occur in 75% of patients who had atypical symptoms.
A positive SI was associated with nonacid reflux in 36% of all patients who experienced GERD-related symptoms during the study; 7% of patients with GERD-related symptoms had a positive SI for acid reflux. In contrast, 58% of patients had no reflux associated with their symptoms.
The percentage of patients with typical symptoms associated with reflux (55%) was significantly higher than the percentage of patients with atypical symptoms associated with reflux (25%).
A total of 15 of the symptomatic patients were younger than 16 years. No differences occurred in the types of reflux associated with symptoms between children or adults.
“MII-pH helps to clarify underlying, persistent GERD-related symptoms during PPI therapy,” Dr. Mainie said. “Clinical presentation alone is not sufficient to identify the presence or absence of reflux-causing symptoms.”
Dr. Mainie and his colleagues at the university are gathering data on the outcomes of these patients to determine the role of MII-pH in directing therapy.
ORLANDO, FLA. — A new diagnostic tool that can detect reflux regardless of pH may help clinicians offer individualized treatment for gastroesophageal reflux disease, Inder Mainie, M.D., said at the annual meeting of the American College of Gastroenterology.
Used in conjunction with esophageal pH monitoring, multichannel intraluminal impedance (MII) monitoring can show whether symptoms of gastroesophageal reflux disease (GERD) are associated with acid or nonacid reflux events—or with no reflux at all, said Dr. Mainie of the digestive disease center at the Medical University of South Carolina, Charleston.
About 35% or more of patients with GERD have persistent reflux symptoms while on proton-pump inhibitor (PPI) therapy, Dr. Mainie noted.
Esophageal pH monitoring alone cannot detect reflux episodes that occur at a pH level of 4 or higher (nonacid reflux). But MII devices can detect gastroesophageal reflux independent of pH level based on the changes in the electrical conductivity in the lumen of the esophagus.
A combined approach that uses MII plus pH detection “brings a change in the paradigm for reflux detection,” Dr. Mainie said. “The impedance information identifies reflux episodes, while the pH electrode is used simply to categorize them as acid or nonacid.”
In 125 patients (average age 43 years) who had symptoms of GERD and who took PPIs twice per day, Dr. Mainie and his colleagues simultaneously measured acid and nonacid reflux at 3, 5, 7, 9, 15, and 17 cm above the lower esophageal sphincter with a combined MII-pH device that has been approved by the Food and Drug Administration.
Overall, 101 of the patients had reflux symptoms on the day of the testing. Each patient had nonacid reflux events. Typical GERD symptoms (heartburn, regurgitation, and chest pain) occurred in 58 of the patients.
Among these patients, a positive symptom index occurred with nonacid reflux in 45% and with acid reflux in 10%. Another 45% of patients had typical symptoms without reflux.
The symptom index (SI) represents the percentage of perceived gastroesophageal reflux-related symptoms that correlate with esophageal acid (or nonacid) reflux events. An SI score is positive if 50% or more of the perceived gastroesophageal reflux-related symptoms correlate with acid (or nonacid) reflux events.
In 43 patients who showed atypical GERD symptoms (abdominal discomfort, belch, catarrh, dysphagia, choking, globus, hoarseness, cough, wheeze, or acid taste), a positive SI occurred with nonacid reflux in 23% and with acid reflux in 2% of the patients. Reflux did not occur in 75% of patients who had atypical symptoms.
A positive SI was associated with nonacid reflux in 36% of all patients who experienced GERD-related symptoms during the study; 7% of patients with GERD-related symptoms had a positive SI for acid reflux. In contrast, 58% of patients had no reflux associated with their symptoms.
The percentage of patients with typical symptoms associated with reflux (55%) was significantly higher than the percentage of patients with atypical symptoms associated with reflux (25%).
A total of 15 of the symptomatic patients were younger than 16 years. No differences occurred in the types of reflux associated with symptoms between children or adults.
“MII-pH helps to clarify underlying, persistent GERD-related symptoms during PPI therapy,” Dr. Mainie said. “Clinical presentation alone is not sufficient to identify the presence or absence of reflux-causing symptoms.”
Dr. Mainie and his colleagues at the university are gathering data on the outcomes of these patients to determine the role of MII-pH in directing therapy.
CONCeRN Data Back Colonoscopy for Women
ORLANDO, FLA. — Colonoscopy may be the preferred method of screening for colorectal cancer in women because many of their cancers occur in the right colon, Philip S. Schoenfeld, M.D., reported at the annual meeting of the American College of Gastroenterology.
That conclusion differs from some researchers' suggestion that low-risk women aged 50-59 years who screen negative via flexible sigmoidoscopy might not need colonoscopy because they are at low risk for colorectal cancer (CRC). These researchers have suggested that performing colonoscopies in such women might be stretching the limited endoscopic resources too thin.
The problem is that flexible sigmoidoscopy may find only about one-third of the women who have advanced neoplasia on colonoscopy, said Dr. Schoenfeld of the University of Michigan, Ann Arbor.
He reached that conclusion when he saw the results of the Colorectal Neoplasia Screening With Colonoscopy in Asymptomatic Women at Regional Navy/Army Medical Centers (CONCeRN) trial. Dr. Schoenfeld was the primary investigator in the study, which included asymptomatic women between 50 and 79 years of age referred for CRC screening and asymptomatic women 40-79 years of age with positive family history of CRC who had undergone colonoscopies at Naval medical centers.
The study excluded women who had undergone flexible sigmoidoscopy in the previous 5 years or colonoscopy or barium enema in the last 10 years or who had a history of a positive fecal occult blood test (FOBT), adenomas, iron-deficiency anemia, polyposis syndrome, inflammatory bowel disease, or hematochezia, or weight loss in the last 6 months.
Of 1,463 women who had a colonoscopy completed to the cecum, 4.9% had advanced neoplasia, including adenomas larger than 10 mm, adenomas with high-grade dysplasia, villose adenomas, or CRC. The incidence of advanced neoplasia increased with age: 3.8% in 50- to 59-year-olds, 4.9% in 60- to 69-year-olds, and 7.6% in 70- to 79-year-olds.
The investigators compared the women in the CONCeRN trial with asymptomatic men referred for CRC screening via colonoscopy from Veterans Affairs Cooperative Study 380 (N. Engl. J. Med. 2000;343:162-8). About 10% of men from that study had advanced neoplasia.
Dr. Schoenfeld and his associates estimated the diagnostic yield of flexible sigmoidoscopy by examining the proportion of patients with advanced neoplasia in the left (distal) colon. Patients also were included in the diagnostic yield of flexible sigmoidoscopy if they had small adenomas in the distal colon—which normally necessitate a colonoscopy—and then were found to have advanced neoplasia in the proximal (right) colon.
When men and women from the two trials were matched for age, negative FOBT status, and negative family history of CRC, advanced neoplasia was found in significantly more men aged 50-59 years (4.7%) and 60-69 years (10.6%) than in women aged 50-59 years (2.9%) and 60-69 years (5%).But in women, advanced neoplasia occurred significantly more often in the right than in the left colon. Flexible sigmoidoscopy would have had an estimated diagnostic yield of only 35% in these women. This is significantly less than the estimated diagnostic yield of 66% obtained by flexible sigmoidoscopy in men in the Veterans Affairs study.
If flexible sigmoidoscopy had been performed in all the women in the CONCeRN trial, advanced neoplasia would have been found in only 1.7%, and 3.2% with advanced neoplasia would have been missed, he said.
Flexible sigmoidoscopy would have missed more cases of advanced neoplasia in women than in men, despite its increased prevalence in men, because of its left-sided distribution in men, Dr. Schoenfeld added.
ORLANDO, FLA. — Colonoscopy may be the preferred method of screening for colorectal cancer in women because many of their cancers occur in the right colon, Philip S. Schoenfeld, M.D., reported at the annual meeting of the American College of Gastroenterology.
That conclusion differs from some researchers' suggestion that low-risk women aged 50-59 years who screen negative via flexible sigmoidoscopy might not need colonoscopy because they are at low risk for colorectal cancer (CRC). These researchers have suggested that performing colonoscopies in such women might be stretching the limited endoscopic resources too thin.
The problem is that flexible sigmoidoscopy may find only about one-third of the women who have advanced neoplasia on colonoscopy, said Dr. Schoenfeld of the University of Michigan, Ann Arbor.
He reached that conclusion when he saw the results of the Colorectal Neoplasia Screening With Colonoscopy in Asymptomatic Women at Regional Navy/Army Medical Centers (CONCeRN) trial. Dr. Schoenfeld was the primary investigator in the study, which included asymptomatic women between 50 and 79 years of age referred for CRC screening and asymptomatic women 40-79 years of age with positive family history of CRC who had undergone colonoscopies at Naval medical centers.
The study excluded women who had undergone flexible sigmoidoscopy in the previous 5 years or colonoscopy or barium enema in the last 10 years or who had a history of a positive fecal occult blood test (FOBT), adenomas, iron-deficiency anemia, polyposis syndrome, inflammatory bowel disease, or hematochezia, or weight loss in the last 6 months.
Of 1,463 women who had a colonoscopy completed to the cecum, 4.9% had advanced neoplasia, including adenomas larger than 10 mm, adenomas with high-grade dysplasia, villose adenomas, or CRC. The incidence of advanced neoplasia increased with age: 3.8% in 50- to 59-year-olds, 4.9% in 60- to 69-year-olds, and 7.6% in 70- to 79-year-olds.
The investigators compared the women in the CONCeRN trial with asymptomatic men referred for CRC screening via colonoscopy from Veterans Affairs Cooperative Study 380 (N. Engl. J. Med. 2000;343:162-8). About 10% of men from that study had advanced neoplasia.
Dr. Schoenfeld and his associates estimated the diagnostic yield of flexible sigmoidoscopy by examining the proportion of patients with advanced neoplasia in the left (distal) colon. Patients also were included in the diagnostic yield of flexible sigmoidoscopy if they had small adenomas in the distal colon—which normally necessitate a colonoscopy—and then were found to have advanced neoplasia in the proximal (right) colon.
When men and women from the two trials were matched for age, negative FOBT status, and negative family history of CRC, advanced neoplasia was found in significantly more men aged 50-59 years (4.7%) and 60-69 years (10.6%) than in women aged 50-59 years (2.9%) and 60-69 years (5%).But in women, advanced neoplasia occurred significantly more often in the right than in the left colon. Flexible sigmoidoscopy would have had an estimated diagnostic yield of only 35% in these women. This is significantly less than the estimated diagnostic yield of 66% obtained by flexible sigmoidoscopy in men in the Veterans Affairs study.
If flexible sigmoidoscopy had been performed in all the women in the CONCeRN trial, advanced neoplasia would have been found in only 1.7%, and 3.2% with advanced neoplasia would have been missed, he said.
Flexible sigmoidoscopy would have missed more cases of advanced neoplasia in women than in men, despite its increased prevalence in men, because of its left-sided distribution in men, Dr. Schoenfeld added.
ORLANDO, FLA. — Colonoscopy may be the preferred method of screening for colorectal cancer in women because many of their cancers occur in the right colon, Philip S. Schoenfeld, M.D., reported at the annual meeting of the American College of Gastroenterology.
That conclusion differs from some researchers' suggestion that low-risk women aged 50-59 years who screen negative via flexible sigmoidoscopy might not need colonoscopy because they are at low risk for colorectal cancer (CRC). These researchers have suggested that performing colonoscopies in such women might be stretching the limited endoscopic resources too thin.
The problem is that flexible sigmoidoscopy may find only about one-third of the women who have advanced neoplasia on colonoscopy, said Dr. Schoenfeld of the University of Michigan, Ann Arbor.
He reached that conclusion when he saw the results of the Colorectal Neoplasia Screening With Colonoscopy in Asymptomatic Women at Regional Navy/Army Medical Centers (CONCeRN) trial. Dr. Schoenfeld was the primary investigator in the study, which included asymptomatic women between 50 and 79 years of age referred for CRC screening and asymptomatic women 40-79 years of age with positive family history of CRC who had undergone colonoscopies at Naval medical centers.
The study excluded women who had undergone flexible sigmoidoscopy in the previous 5 years or colonoscopy or barium enema in the last 10 years or who had a history of a positive fecal occult blood test (FOBT), adenomas, iron-deficiency anemia, polyposis syndrome, inflammatory bowel disease, or hematochezia, or weight loss in the last 6 months.
Of 1,463 women who had a colonoscopy completed to the cecum, 4.9% had advanced neoplasia, including adenomas larger than 10 mm, adenomas with high-grade dysplasia, villose adenomas, or CRC. The incidence of advanced neoplasia increased with age: 3.8% in 50- to 59-year-olds, 4.9% in 60- to 69-year-olds, and 7.6% in 70- to 79-year-olds.
The investigators compared the women in the CONCeRN trial with asymptomatic men referred for CRC screening via colonoscopy from Veterans Affairs Cooperative Study 380 (N. Engl. J. Med. 2000;343:162-8). About 10% of men from that study had advanced neoplasia.
Dr. Schoenfeld and his associates estimated the diagnostic yield of flexible sigmoidoscopy by examining the proportion of patients with advanced neoplasia in the left (distal) colon. Patients also were included in the diagnostic yield of flexible sigmoidoscopy if they had small adenomas in the distal colon—which normally necessitate a colonoscopy—and then were found to have advanced neoplasia in the proximal (right) colon.
When men and women from the two trials were matched for age, negative FOBT status, and negative family history of CRC, advanced neoplasia was found in significantly more men aged 50-59 years (4.7%) and 60-69 years (10.6%) than in women aged 50-59 years (2.9%) and 60-69 years (5%).But in women, advanced neoplasia occurred significantly more often in the right than in the left colon. Flexible sigmoidoscopy would have had an estimated diagnostic yield of only 35% in these women. This is significantly less than the estimated diagnostic yield of 66% obtained by flexible sigmoidoscopy in men in the Veterans Affairs study.
If flexible sigmoidoscopy had been performed in all the women in the CONCeRN trial, advanced neoplasia would have been found in only 1.7%, and 3.2% with advanced neoplasia would have been missed, he said.
Flexible sigmoidoscopy would have missed more cases of advanced neoplasia in women than in men, despite its increased prevalence in men, because of its left-sided distribution in men, Dr. Schoenfeld added.
Capsule Endoscopy Used to Diagnose Ca, Crohn's
ORLANDO, FLA. — Indications for capsule endoscopy may expand in the future as researchers investigate new ways to use the technique in the small bowel to detect disease, evaluate its extent, or locate its cause, David R. Cave, M.D., said at the annual meeting of the American College of Gastroenterology.
Capsule endoscopy with the Pillcam SB (formerly called the M2A video capsule) is indicated for obscure GI bleeding, suspected small bowel tumors, and suspected Crohn's disease, although many insurers do not cover the last two indications, said Dr. Cave, professor of medicine at Tufts University, Boston.
He discussed some of the current areas of research on capsule endoscopy:
▸ GI bleeding without hematemesis. This condition can be difficult to evaluate if the hospital does not have a 24-hour bleeding team in the emergency department that can provide support in the detection of GI bleeding. Dr. Cave and his colleagues thought they might be able to save time with capsule endoscopy and still diagnose GI bleeding without hematemesis accurately. At St. Elizabeth's Medical Center in Brighton, Mass., they used capsule endoscopy to investigate the source of bleeding in 24 patients.
In the randomized feasibility study, 16 patients underwent capsule endoscopy within 4 hours of arriving at the emergency department, with further endoscopic procedures if needed. After capsule endoscopy finished, the investigators immediately interpreted the data and provided the information to the attending physician on the GI team without making any recommendations. Another eight patients first received a conventional work-up with esophagogastroduodenoscopy (EGD) and colonoscopy before they underwent capsule endoscopy more than 4 hours after presenting to the emergency department.
The patients who received capsule endoscopy early had a specific diagnosis in a median of 19 hours, compared with 35 hours in the patients who had capsule endoscopy later. Capsule endoscopy located active bleeding in 13 of 24 patients, while EGD detected active bleeding in 2 of 17 patients and colonoscopy found it in 0 of 13 patients.
▸ Suspected Crohn's disease. Capsule endoscopy can be used to verify the presence of Crohn's disease and other inflammatory bowel diseases in the small bowel, and it may turn out to be even more valuable: A Crohn's disease activity index based on capsule endoscopy is being developed.
The technique also may be used to assess the extent of disease, especially in preparing for surgery or assessing the degree of healing before and after treatment with some of the new biologic medications, Dr. Cave said.
▸ Celiac disease. Clinicians can take duodenal biopsies and perform serologic tests to diagnose celiac disease, but they haven't really been able to measure the extent of disease. Capsule endoscopy should help to visualize neoplasias, such as lymphomas or adenomas, and ulceration that can occur in patients with celiac disease. The technique also should be able to detect coexistent inflammatory bowel disease.
▸ Abdominal pain. Capsule endoscopy may be useful in patients who present to the emergency department with abdominal pain for which it is difficult to distinguish between an organic disease and a pain syndrome. Only about 15% of people with abdominal pain turn out to have structural abnormalities. The goal is to avoid repeat endoscopies and CT scans in patients without lesions; instead, these patients can be treated for a pain syndrome. But there is currently very little research on this issue, Dr. Cave said, “maybe because insurance carriers are not paying for this indication.”
▸ Chronic diarrhea. Gastroenterologists may sometimes give “short shrift” to patients with substantial diarrhea by diagnosing them with diarrhea-predominant irritable bowel syndrome, Dr. Cave suggested. Full-thickness biopsies taken during laparoscopy in these patients have shown lymphocytic infiltration of the myenteric plexus. Capsule endoscopy could help to determine if there is a counterpart to this infiltration in the small bowel mucosa. No systematic study has examined mucosal changes in these patients, he noted.
Capsule endoscopy also may be able to help researchers understand the nature of the Brainerd diarrhea syndrome, which is “often labeled as [irritable bowel syndrome], but it might not be,” he said. Brainerd diarrhea syndrome is an acute condition that can occur sporadically or in outbreaks and may last for months to years. It “probably has an infectious etiology,” Dr. Cave said.
▸ Small bowel obstruction. Gastroenterologists initially had great concern that a retained capsule in patients with small bowel obstruction would cause trouble, “but some of us have started to look at capsule retention now in a more positive light and are actually using it as a means of detecting patients who have small bowel obstruction with no definable source,” he said. It's important to get consent from patients and explain to them that in this procedure, you are actually expecting the capsule to be retained, Dr. Cave advised. The gastroenterologist must work with a surgeon to arrange laparoscopic surgery and, possibly, intraoperative enteroscopy.
▸ Surveillance of polyposis syndromes. Work is just starting in this area, for the detection of conditions such as familial adenomatous polyposis and Peutz-Jeghers syndrome. Little is known about how often these patients should undergo surveillance with capsule endoscopy and what should be done about the results.
ORLANDO, FLA. — Indications for capsule endoscopy may expand in the future as researchers investigate new ways to use the technique in the small bowel to detect disease, evaluate its extent, or locate its cause, David R. Cave, M.D., said at the annual meeting of the American College of Gastroenterology.
Capsule endoscopy with the Pillcam SB (formerly called the M2A video capsule) is indicated for obscure GI bleeding, suspected small bowel tumors, and suspected Crohn's disease, although many insurers do not cover the last two indications, said Dr. Cave, professor of medicine at Tufts University, Boston.
He discussed some of the current areas of research on capsule endoscopy:
▸ GI bleeding without hematemesis. This condition can be difficult to evaluate if the hospital does not have a 24-hour bleeding team in the emergency department that can provide support in the detection of GI bleeding. Dr. Cave and his colleagues thought they might be able to save time with capsule endoscopy and still diagnose GI bleeding without hematemesis accurately. At St. Elizabeth's Medical Center in Brighton, Mass., they used capsule endoscopy to investigate the source of bleeding in 24 patients.
In the randomized feasibility study, 16 patients underwent capsule endoscopy within 4 hours of arriving at the emergency department, with further endoscopic procedures if needed. After capsule endoscopy finished, the investigators immediately interpreted the data and provided the information to the attending physician on the GI team without making any recommendations. Another eight patients first received a conventional work-up with esophagogastroduodenoscopy (EGD) and colonoscopy before they underwent capsule endoscopy more than 4 hours after presenting to the emergency department.
The patients who received capsule endoscopy early had a specific diagnosis in a median of 19 hours, compared with 35 hours in the patients who had capsule endoscopy later. Capsule endoscopy located active bleeding in 13 of 24 patients, while EGD detected active bleeding in 2 of 17 patients and colonoscopy found it in 0 of 13 patients.
▸ Suspected Crohn's disease. Capsule endoscopy can be used to verify the presence of Crohn's disease and other inflammatory bowel diseases in the small bowel, and it may turn out to be even more valuable: A Crohn's disease activity index based on capsule endoscopy is being developed.
The technique also may be used to assess the extent of disease, especially in preparing for surgery or assessing the degree of healing before and after treatment with some of the new biologic medications, Dr. Cave said.
▸ Celiac disease. Clinicians can take duodenal biopsies and perform serologic tests to diagnose celiac disease, but they haven't really been able to measure the extent of disease. Capsule endoscopy should help to visualize neoplasias, such as lymphomas or adenomas, and ulceration that can occur in patients with celiac disease. The technique also should be able to detect coexistent inflammatory bowel disease.
▸ Abdominal pain. Capsule endoscopy may be useful in patients who present to the emergency department with abdominal pain for which it is difficult to distinguish between an organic disease and a pain syndrome. Only about 15% of people with abdominal pain turn out to have structural abnormalities. The goal is to avoid repeat endoscopies and CT scans in patients without lesions; instead, these patients can be treated for a pain syndrome. But there is currently very little research on this issue, Dr. Cave said, “maybe because insurance carriers are not paying for this indication.”
▸ Chronic diarrhea. Gastroenterologists may sometimes give “short shrift” to patients with substantial diarrhea by diagnosing them with diarrhea-predominant irritable bowel syndrome, Dr. Cave suggested. Full-thickness biopsies taken during laparoscopy in these patients have shown lymphocytic infiltration of the myenteric plexus. Capsule endoscopy could help to determine if there is a counterpart to this infiltration in the small bowel mucosa. No systematic study has examined mucosal changes in these patients, he noted.
Capsule endoscopy also may be able to help researchers understand the nature of the Brainerd diarrhea syndrome, which is “often labeled as [irritable bowel syndrome], but it might not be,” he said. Brainerd diarrhea syndrome is an acute condition that can occur sporadically or in outbreaks and may last for months to years. It “probably has an infectious etiology,” Dr. Cave said.
▸ Small bowel obstruction. Gastroenterologists initially had great concern that a retained capsule in patients with small bowel obstruction would cause trouble, “but some of us have started to look at capsule retention now in a more positive light and are actually using it as a means of detecting patients who have small bowel obstruction with no definable source,” he said. It's important to get consent from patients and explain to them that in this procedure, you are actually expecting the capsule to be retained, Dr. Cave advised. The gastroenterologist must work with a surgeon to arrange laparoscopic surgery and, possibly, intraoperative enteroscopy.
▸ Surveillance of polyposis syndromes. Work is just starting in this area, for the detection of conditions such as familial adenomatous polyposis and Peutz-Jeghers syndrome. Little is known about how often these patients should undergo surveillance with capsule endoscopy and what should be done about the results.
ORLANDO, FLA. — Indications for capsule endoscopy may expand in the future as researchers investigate new ways to use the technique in the small bowel to detect disease, evaluate its extent, or locate its cause, David R. Cave, M.D., said at the annual meeting of the American College of Gastroenterology.
Capsule endoscopy with the Pillcam SB (formerly called the M2A video capsule) is indicated for obscure GI bleeding, suspected small bowel tumors, and suspected Crohn's disease, although many insurers do not cover the last two indications, said Dr. Cave, professor of medicine at Tufts University, Boston.
He discussed some of the current areas of research on capsule endoscopy:
▸ GI bleeding without hematemesis. This condition can be difficult to evaluate if the hospital does not have a 24-hour bleeding team in the emergency department that can provide support in the detection of GI bleeding. Dr. Cave and his colleagues thought they might be able to save time with capsule endoscopy and still diagnose GI bleeding without hematemesis accurately. At St. Elizabeth's Medical Center in Brighton, Mass., they used capsule endoscopy to investigate the source of bleeding in 24 patients.
In the randomized feasibility study, 16 patients underwent capsule endoscopy within 4 hours of arriving at the emergency department, with further endoscopic procedures if needed. After capsule endoscopy finished, the investigators immediately interpreted the data and provided the information to the attending physician on the GI team without making any recommendations. Another eight patients first received a conventional work-up with esophagogastroduodenoscopy (EGD) and colonoscopy before they underwent capsule endoscopy more than 4 hours after presenting to the emergency department.
The patients who received capsule endoscopy early had a specific diagnosis in a median of 19 hours, compared with 35 hours in the patients who had capsule endoscopy later. Capsule endoscopy located active bleeding in 13 of 24 patients, while EGD detected active bleeding in 2 of 17 patients and colonoscopy found it in 0 of 13 patients.
▸ Suspected Crohn's disease. Capsule endoscopy can be used to verify the presence of Crohn's disease and other inflammatory bowel diseases in the small bowel, and it may turn out to be even more valuable: A Crohn's disease activity index based on capsule endoscopy is being developed.
The technique also may be used to assess the extent of disease, especially in preparing for surgery or assessing the degree of healing before and after treatment with some of the new biologic medications, Dr. Cave said.
▸ Celiac disease. Clinicians can take duodenal biopsies and perform serologic tests to diagnose celiac disease, but they haven't really been able to measure the extent of disease. Capsule endoscopy should help to visualize neoplasias, such as lymphomas or adenomas, and ulceration that can occur in patients with celiac disease. The technique also should be able to detect coexistent inflammatory bowel disease.
▸ Abdominal pain. Capsule endoscopy may be useful in patients who present to the emergency department with abdominal pain for which it is difficult to distinguish between an organic disease and a pain syndrome. Only about 15% of people with abdominal pain turn out to have structural abnormalities. The goal is to avoid repeat endoscopies and CT scans in patients without lesions; instead, these patients can be treated for a pain syndrome. But there is currently very little research on this issue, Dr. Cave said, “maybe because insurance carriers are not paying for this indication.”
▸ Chronic diarrhea. Gastroenterologists may sometimes give “short shrift” to patients with substantial diarrhea by diagnosing them with diarrhea-predominant irritable bowel syndrome, Dr. Cave suggested. Full-thickness biopsies taken during laparoscopy in these patients have shown lymphocytic infiltration of the myenteric plexus. Capsule endoscopy could help to determine if there is a counterpart to this infiltration in the small bowel mucosa. No systematic study has examined mucosal changes in these patients, he noted.
Capsule endoscopy also may be able to help researchers understand the nature of the Brainerd diarrhea syndrome, which is “often labeled as [irritable bowel syndrome], but it might not be,” he said. Brainerd diarrhea syndrome is an acute condition that can occur sporadically or in outbreaks and may last for months to years. It “probably has an infectious etiology,” Dr. Cave said.
▸ Small bowel obstruction. Gastroenterologists initially had great concern that a retained capsule in patients with small bowel obstruction would cause trouble, “but some of us have started to look at capsule retention now in a more positive light and are actually using it as a means of detecting patients who have small bowel obstruction with no definable source,” he said. It's important to get consent from patients and explain to them that in this procedure, you are actually expecting the capsule to be retained, Dr. Cave advised. The gastroenterologist must work with a surgeon to arrange laparoscopic surgery and, possibly, intraoperative enteroscopy.
▸ Surveillance of polyposis syndromes. Work is just starting in this area, for the detection of conditions such as familial adenomatous polyposis and Peutz-Jeghers syndrome. Little is known about how often these patients should undergo surveillance with capsule endoscopy and what should be done about the results.
New Video Capsule Screens for Esophageal Lesions : Pillcam ESO is designed to detect premalignant changes, but does not replace traditional endoscopy.
ORLANDO, FLA. — A novel video capsule device for imaging the esophagus appears to detect esophagitis and Barrett's esophagus just as well as traditional endoscopy in patients with chronic symptoms of gastroesophageal reflux disease, according to the results of a prospective, multicenter study.
The U.S. Food and Drug Administration approved Pillcam ESO for the detection of esophageal pathologies in late October.
The new device is similar to the M2A capsule (now called Pillcam SB) but has cameras on each end of the pill to capture a total of four frames per second. Both of the devices are manufactured by Given Imaging Ltd.
Pillcam ESO, which is meant to be an easy screening procedure for potential premalignant lesions, “is not meant to replace a traditional endoscope,” Rami Eliakim, M.D., said at the annual meeting of the American College of Gastroenterology.
Use of the device for widespread screening may lead to an increase in the number of patients undergoing traditional endoscopy, he added, noting that many gastroenterologists regularly perform endoscopic screening of patients with Barrett's esophagus who have chronic GERD symptoms.
Up to 10% of white male patients with chronic GERD may have Barrett's esophagus. Studies suggest that patients with Barrett's esophagus develop esophageal adenocarcinoma at a rate of 0.5% per year.
Recent studies have shown that screening 50-year-old men with chronic GERD symptoms for esophageal adenocarcinoma “is probably cost-effective,” said Dr. Eliakim of Rambam Medical Center, Haifa, Israel.
Following a 6-hour fast, 109 patients with a mean age of 51 years ingested Pillcam ESO in the supine position, then underwent traditional endoscopy 30 minutes later with 2.5-5 mg of IV midazolam (Versed). One patient could not swallow Pillcam, and images could not be viewed in two other patients. Individuals with dysphagia, Zenker's diverticulum, suspected intestinal obstruction, major abdominal surgery within the last 6 months, or cardiac pacemakers did not participate—nor did pregnant or breast-feeding women.
Of the 106 remaining patients, 61 had positive and 38 had negative findings on both traditional and capsule endoscopy. In five patients, traditional endoscopy made a positive finding when capsule endoscopy did not. Two patients had positive findings with capsule endoscopy when traditional endoscopy found nothing.
Barrett's esophagus was not confirmed histologically in all of the patients who showed signs of the condition during capsule endoscopy.
Based on those results, Pillcam ESO had 92% sensitivity, 95% specificity, 97% positive predictive value, and 88% negative predictive value for detecting either Barrett's esophagus or esophagitis.
Capsule endoscopy with Pillcam ESO detected Barrett's esophagus with 97% sensitivity and 99% specificity. Pillcam ESO reached 89% sensitivity and 99% specificity in patients with esophagitis.
Patients may prefer using capsule endoscopy instead of the traditional procedure, which involves recovering from sedation, Dr. Eliakim said.
Patients in the study gave Pillcam ESO a significantly better rating than traditional endoscopy in response to questions regarding ease of swallowing, comfort with the procedure, and overall convenience.
Dr. Eliakim said the cost of capsule endoscopy of the esophagus with Pillcam ESO is not yet known.
ORLANDO, FLA. — A novel video capsule device for imaging the esophagus appears to detect esophagitis and Barrett's esophagus just as well as traditional endoscopy in patients with chronic symptoms of gastroesophageal reflux disease, according to the results of a prospective, multicenter study.
The U.S. Food and Drug Administration approved Pillcam ESO for the detection of esophageal pathologies in late October.
The new device is similar to the M2A capsule (now called Pillcam SB) but has cameras on each end of the pill to capture a total of four frames per second. Both of the devices are manufactured by Given Imaging Ltd.
Pillcam ESO, which is meant to be an easy screening procedure for potential premalignant lesions, “is not meant to replace a traditional endoscope,” Rami Eliakim, M.D., said at the annual meeting of the American College of Gastroenterology.
Use of the device for widespread screening may lead to an increase in the number of patients undergoing traditional endoscopy, he added, noting that many gastroenterologists regularly perform endoscopic screening of patients with Barrett's esophagus who have chronic GERD symptoms.
Up to 10% of white male patients with chronic GERD may have Barrett's esophagus. Studies suggest that patients with Barrett's esophagus develop esophageal adenocarcinoma at a rate of 0.5% per year.
Recent studies have shown that screening 50-year-old men with chronic GERD symptoms for esophageal adenocarcinoma “is probably cost-effective,” said Dr. Eliakim of Rambam Medical Center, Haifa, Israel.
Following a 6-hour fast, 109 patients with a mean age of 51 years ingested Pillcam ESO in the supine position, then underwent traditional endoscopy 30 minutes later with 2.5-5 mg of IV midazolam (Versed). One patient could not swallow Pillcam, and images could not be viewed in two other patients. Individuals with dysphagia, Zenker's diverticulum, suspected intestinal obstruction, major abdominal surgery within the last 6 months, or cardiac pacemakers did not participate—nor did pregnant or breast-feeding women.
Of the 106 remaining patients, 61 had positive and 38 had negative findings on both traditional and capsule endoscopy. In five patients, traditional endoscopy made a positive finding when capsule endoscopy did not. Two patients had positive findings with capsule endoscopy when traditional endoscopy found nothing.
Barrett's esophagus was not confirmed histologically in all of the patients who showed signs of the condition during capsule endoscopy.
Based on those results, Pillcam ESO had 92% sensitivity, 95% specificity, 97% positive predictive value, and 88% negative predictive value for detecting either Barrett's esophagus or esophagitis.
Capsule endoscopy with Pillcam ESO detected Barrett's esophagus with 97% sensitivity and 99% specificity. Pillcam ESO reached 89% sensitivity and 99% specificity in patients with esophagitis.
Patients may prefer using capsule endoscopy instead of the traditional procedure, which involves recovering from sedation, Dr. Eliakim said.
Patients in the study gave Pillcam ESO a significantly better rating than traditional endoscopy in response to questions regarding ease of swallowing, comfort with the procedure, and overall convenience.
Dr. Eliakim said the cost of capsule endoscopy of the esophagus with Pillcam ESO is not yet known.
ORLANDO, FLA. — A novel video capsule device for imaging the esophagus appears to detect esophagitis and Barrett's esophagus just as well as traditional endoscopy in patients with chronic symptoms of gastroesophageal reflux disease, according to the results of a prospective, multicenter study.
The U.S. Food and Drug Administration approved Pillcam ESO for the detection of esophageal pathologies in late October.
The new device is similar to the M2A capsule (now called Pillcam SB) but has cameras on each end of the pill to capture a total of four frames per second. Both of the devices are manufactured by Given Imaging Ltd.
Pillcam ESO, which is meant to be an easy screening procedure for potential premalignant lesions, “is not meant to replace a traditional endoscope,” Rami Eliakim, M.D., said at the annual meeting of the American College of Gastroenterology.
Use of the device for widespread screening may lead to an increase in the number of patients undergoing traditional endoscopy, he added, noting that many gastroenterologists regularly perform endoscopic screening of patients with Barrett's esophagus who have chronic GERD symptoms.
Up to 10% of white male patients with chronic GERD may have Barrett's esophagus. Studies suggest that patients with Barrett's esophagus develop esophageal adenocarcinoma at a rate of 0.5% per year.
Recent studies have shown that screening 50-year-old men with chronic GERD symptoms for esophageal adenocarcinoma “is probably cost-effective,” said Dr. Eliakim of Rambam Medical Center, Haifa, Israel.
Following a 6-hour fast, 109 patients with a mean age of 51 years ingested Pillcam ESO in the supine position, then underwent traditional endoscopy 30 minutes later with 2.5-5 mg of IV midazolam (Versed). One patient could not swallow Pillcam, and images could not be viewed in two other patients. Individuals with dysphagia, Zenker's diverticulum, suspected intestinal obstruction, major abdominal surgery within the last 6 months, or cardiac pacemakers did not participate—nor did pregnant or breast-feeding women.
Of the 106 remaining patients, 61 had positive and 38 had negative findings on both traditional and capsule endoscopy. In five patients, traditional endoscopy made a positive finding when capsule endoscopy did not. Two patients had positive findings with capsule endoscopy when traditional endoscopy found nothing.
Barrett's esophagus was not confirmed histologically in all of the patients who showed signs of the condition during capsule endoscopy.
Based on those results, Pillcam ESO had 92% sensitivity, 95% specificity, 97% positive predictive value, and 88% negative predictive value for detecting either Barrett's esophagus or esophagitis.
Capsule endoscopy with Pillcam ESO detected Barrett's esophagus with 97% sensitivity and 99% specificity. Pillcam ESO reached 89% sensitivity and 99% specificity in patients with esophagitis.
Patients may prefer using capsule endoscopy instead of the traditional procedure, which involves recovering from sedation, Dr. Eliakim said.
Patients in the study gave Pillcam ESO a significantly better rating than traditional endoscopy in response to questions regarding ease of swallowing, comfort with the procedure, and overall convenience.
Dr. Eliakim said the cost of capsule endoscopy of the esophagus with Pillcam ESO is not yet known.
Probiotic No Help Against Yeast Infection
Lactobacillus taken after a course of antibiotics for a nongynecologic infection does not prevent vaginal yeast infections, reported Marie Pirotta, M.B., and her colleagues at the University of Melbourne (Australia).
The benefits of probiotics such as lactobacillus have long been promoted for overall health and for vaginal problems specifically. A previous study conducted by Dr. Pirotta and her associates found that 40% of 751 women with a history of vulvovaginitis had eaten yogurt or administered lactobacillus orally or vaginally to prevent vulvovaginitis after they had taken antibiotics.
In their subsequent 14-day double-blind study, 235 women were randomized to one of four treatment groups: oral plus vaginal lactobacillus, oral lactobacillus plus vaginal placebo, oral placebo plus vaginal lactobacillus, and oral and vaginal placebo (BMJ 2004;329:548).
Overall, 55 women developed postantibiotic vulvovaginitis, ranging from 17% to 29% of the women in each of the four groups. Compared with placebo, the odds ratio for developing vulvovaginitis was 1.06 with oral lactobacillus and 1.38 with vaginal lactobacillus.
“Our results should prompt health professionals to inform women that lactobacillus is unlikely to prevent postantibiotic vulvovaginitis and that they should consider using proven antifungal treatment if symptoms develop,” the investigators said.
Lactobacillus taken after a course of antibiotics for a nongynecologic infection does not prevent vaginal yeast infections, reported Marie Pirotta, M.B., and her colleagues at the University of Melbourne (Australia).
The benefits of probiotics such as lactobacillus have long been promoted for overall health and for vaginal problems specifically. A previous study conducted by Dr. Pirotta and her associates found that 40% of 751 women with a history of vulvovaginitis had eaten yogurt or administered lactobacillus orally or vaginally to prevent vulvovaginitis after they had taken antibiotics.
In their subsequent 14-day double-blind study, 235 women were randomized to one of four treatment groups: oral plus vaginal lactobacillus, oral lactobacillus plus vaginal placebo, oral placebo plus vaginal lactobacillus, and oral and vaginal placebo (BMJ 2004;329:548).
Overall, 55 women developed postantibiotic vulvovaginitis, ranging from 17% to 29% of the women in each of the four groups. Compared with placebo, the odds ratio for developing vulvovaginitis was 1.06 with oral lactobacillus and 1.38 with vaginal lactobacillus.
“Our results should prompt health professionals to inform women that lactobacillus is unlikely to prevent postantibiotic vulvovaginitis and that they should consider using proven antifungal treatment if symptoms develop,” the investigators said.
Lactobacillus taken after a course of antibiotics for a nongynecologic infection does not prevent vaginal yeast infections, reported Marie Pirotta, M.B., and her colleagues at the University of Melbourne (Australia).
The benefits of probiotics such as lactobacillus have long been promoted for overall health and for vaginal problems specifically. A previous study conducted by Dr. Pirotta and her associates found that 40% of 751 women with a history of vulvovaginitis had eaten yogurt or administered lactobacillus orally or vaginally to prevent vulvovaginitis after they had taken antibiotics.
In their subsequent 14-day double-blind study, 235 women were randomized to one of four treatment groups: oral plus vaginal lactobacillus, oral lactobacillus plus vaginal placebo, oral placebo plus vaginal lactobacillus, and oral and vaginal placebo (BMJ 2004;329:548).
Overall, 55 women developed postantibiotic vulvovaginitis, ranging from 17% to 29% of the women in each of the four groups. Compared with placebo, the odds ratio for developing vulvovaginitis was 1.06 with oral lactobacillus and 1.38 with vaginal lactobacillus.
“Our results should prompt health professionals to inform women that lactobacillus is unlikely to prevent postantibiotic vulvovaginitis and that they should consider using proven antifungal treatment if symptoms develop,” the investigators said.
Quick Fungal Dx With In Situ Hybridization
BOSTON — In situ hybridization may provide a much faster method of diagnosing dimorphic fungal infections than tissue culturing, Jared J. Abbott, M.D., reported at the annual meeting of the American Society of Dermatopathology.
Although tissue culturing is considered the preferred diagnostic method in current practice, it takes time to complete. Often, tissue cultures are not done, said Dr. Abbott, a resident in pathology at the Mayo Clinic, Rochester, Minn.
Cutaneous fungal infections can be the presenting sign of a systemic infection, and thus the skin infection can be secondary. The prognosis of cutaneous fungal infections is heavily dependent on timely diagnosis and treatment, he said in a poster presentation.
Dr. Abbott and his colleagues diagnosed cutaneous infections of dimorphic fungi (histoplasmosis, blastomycosis, coccidiomycosis, or cryptococcosis) in five patients, four of whom were immunocompromised. Within 36-48 hours, in situ hybridization gave the same results as tissue culturing for all patients.
The investigators determined the presence of dimorphic fungi in all of the skin sections via morphology, but none of the organisms were diagnostically discernible.
The in situ hybridization method used by Dr. Abbott and his associates detected fungal ribosomal RNA elements in paraffin-embedded tissue using labeled, single-stranded DNA oligonucleotide probes.
“In situ hybridization has a potential role in distinguishing between organisms of similar morphology in cutaneous fungal infections,” the investigators concluded.
BOSTON — In situ hybridization may provide a much faster method of diagnosing dimorphic fungal infections than tissue culturing, Jared J. Abbott, M.D., reported at the annual meeting of the American Society of Dermatopathology.
Although tissue culturing is considered the preferred diagnostic method in current practice, it takes time to complete. Often, tissue cultures are not done, said Dr. Abbott, a resident in pathology at the Mayo Clinic, Rochester, Minn.
Cutaneous fungal infections can be the presenting sign of a systemic infection, and thus the skin infection can be secondary. The prognosis of cutaneous fungal infections is heavily dependent on timely diagnosis and treatment, he said in a poster presentation.
Dr. Abbott and his colleagues diagnosed cutaneous infections of dimorphic fungi (histoplasmosis, blastomycosis, coccidiomycosis, or cryptococcosis) in five patients, four of whom were immunocompromised. Within 36-48 hours, in situ hybridization gave the same results as tissue culturing for all patients.
The investigators determined the presence of dimorphic fungi in all of the skin sections via morphology, but none of the organisms were diagnostically discernible.
The in situ hybridization method used by Dr. Abbott and his associates detected fungal ribosomal RNA elements in paraffin-embedded tissue using labeled, single-stranded DNA oligonucleotide probes.
“In situ hybridization has a potential role in distinguishing between organisms of similar morphology in cutaneous fungal infections,” the investigators concluded.
BOSTON — In situ hybridization may provide a much faster method of diagnosing dimorphic fungal infections than tissue culturing, Jared J. Abbott, M.D., reported at the annual meeting of the American Society of Dermatopathology.
Although tissue culturing is considered the preferred diagnostic method in current practice, it takes time to complete. Often, tissue cultures are not done, said Dr. Abbott, a resident in pathology at the Mayo Clinic, Rochester, Minn.
Cutaneous fungal infections can be the presenting sign of a systemic infection, and thus the skin infection can be secondary. The prognosis of cutaneous fungal infections is heavily dependent on timely diagnosis and treatment, he said in a poster presentation.
Dr. Abbott and his colleagues diagnosed cutaneous infections of dimorphic fungi (histoplasmosis, blastomycosis, coccidiomycosis, or cryptococcosis) in five patients, four of whom were immunocompromised. Within 36-48 hours, in situ hybridization gave the same results as tissue culturing for all patients.
The investigators determined the presence of dimorphic fungi in all of the skin sections via morphology, but none of the organisms were diagnostically discernible.
The in situ hybridization method used by Dr. Abbott and his associates detected fungal ribosomal RNA elements in paraffin-embedded tissue using labeled, single-stranded DNA oligonucleotide probes.
“In situ hybridization has a potential role in distinguishing between organisms of similar morphology in cutaneous fungal infections,” the investigators concluded.