"This study demonstrates that ECE meets the gold standard of EGD in the detection of abnormalities of the esophagus associated with GERD", stated Blair Lewis, MD, Associate Clinical Professor of The Mount Sinai Medical Center, New York. "A key finding of the study was the accurate visualization of Barrett's esophagus, a precancerous condition that occurs in approximately 10-15 percent of patients with chronic GERD symptoms and may lead to esophageal cancer, the second fastest growing cancer in the western world."
"By providing a patient-friendly alternative, ECE allows us to potentially avoid performing the more invasive conventional endoscopy procedure in a large percentage of patients, and narrow our endoscopic focus on patients that truly need it. Additionally, since patients seem to prefer ECE, we may see an increase in the rate of adherence to screening guidelines which could lead to better clinical outcomes", stated Glenn Eisen, MD, Associate Professor, Oregon Health and Science University in Portland.
The pivotal, multi-national study compared the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the four-frames per second version of the PillCam ESO and EGD in detecting esophagitis, Barrett's esophagus or other esophageal abnormalities in patients with GERD symptoms. Patient satisfaction with each procedure also was assessed. Patients underwent ECE followed by EGD on the same day, and the results of each approach were compared. Physicians were blinded to the results of the earlier test. Data were obtained from 106 patients undergoing endoscopy for evaluation of GERD symptoms or for surveillance of confirmed Barrett's esophagus.
Results show an overall PPV of 97 percent and a NPV of 88 percent in diagnosing esophageal pathology. In detection of Barrett's esophagus PPV and NPV were 97 percent and 99 percent, respectively. PPV and NPV were 97 percent and 94 percent, respectively, in diagnosis of esophagitis. Additionally, patients reported significantly greater satisfaction with ECE compared with EGD in three different measures: ease of insertion, comfort during procedure, and convenience.
For conventional esophageal endoscopy, patients are given conscious sedation and then a small, lighted flexible tube is inserted through the mouth into the esophagus and stomach to examine for abnormalities. Conventional endoscopy is performed by a physician. Conscious sedation-related cardiopulmonary complications are the most common complications associated with conventional endoscopy. Additionally, as a result of the sedation, patients undergoing the procedure usually miss one or two days of work and require transportation assistance in returning home.
With esophageal capsule endoscopy, the patient swallows a capsule that transmits video images of the esophagus to a data recorder that captures the images for subsequent evaluation. The capsule takes just a few minutes to traverse the esophagus, after which the patient can return to daily activities. In studies to date, ECE with PillCam ESO has demonstrated a good safety profile and has been generally well tolerated.
The four-frames per second PillCam ESO video capsule for visual examination of the esophagus was cleared for marketing by the U.S. Food and Drug Administration on October 25, 2004. A "special 510 (k)" application for clearance to market a 14 frames per second PillCam ESO was filed with the FDA on October 26, 2004. Special 510 (k) approvals are typically granted within 30 days, but there can be no assurance that the approval will be granted in that time frame.
According to the American College of Gastroenterology, over 60 million people in the United States alone experience acid indigestion at least once a month and some studies have suggested that over 15 million Americans experience acid indigestion daily. In many cases, proper use of over-the-counter medicines and lifestyle modifications provide effective management of GERD symptoms. Serious complications can occur if GERD is left untreated, including severe chest pain that can mimic a heart attack, esophageal stricture which is a narrowing or obstruction of the esophagus, bleeding, or Barrett's esophagus, a pre-malignant condition of the esophagus.
More news on Given Imaging's PillCam is available in the VMW November 2004 article Given Imaging receives U.S. marketing clearance for Pillcam ESO video capsule for imaging the esophagus and in this VMW issue's article Given Imaging's PillCam SB provides gold standard accuracy in diagnosing small bowel tumours.