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.