News Release

Popular procedures evaluated for diagnostic accuracy and treatment effectiveness

Endotherapy, wireless endoscopy procedures demonstrate various degrees of success

Peer-Reviewed Publication

American Gastroenterological Association

CHICAGO, IL (May 15, 2005) -- A number of new technologies are helpful in diagnosing and treating gastric disorders, while others need more testing, according to new research presented today at Digestive Disease Week® 2005 (DDW). DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

"We continue to see promising new technologies in gastroenterology that are providing significant improvements in quality of life for patients," said Richard Rothstein, M.D., of Dartmouth Medical School. "At the same time, we are evaluating the effectiveness of some procedures in an effort to streamline the treatment of the most widespread gastrointestinal diseases. The overall goal is to maximize the potential of the best procedures for early detection and treatment."

A Prospective Trial Comparing Wireless Capsule Endoscopy and Barium Contrast Series for Small Bowel Surveillance in Hereditary Polyposis Syndromes (Abstract M1368)

Wireless capsule endoscopy, a procedure involving a tiny pill camera, is relatively new and has demonstrated its effectiveness in assessing various conditions in the small intestine. Traditional procedures to identify polyps have included barium contrasts, in which X-ray images are taken after reflective liquid is inserted into the small intestine. In this head-to-head comparison, researchers found the wireless capsule technology performed significantly better than traditional barium X-rays in accurately identifying polyps in the small intestine.

The study examined 24 patients with gastrointestinal diseases using both procedures to locate polyps in the small intestine, recording the number and location of all polyps discovered. The wireless capsule technology identified polyps in seven of the patients, while the barium contrasts found polyps in only three. The polyps in the four patients identified only by the wireless camera were found in all segments of the small intestine–the ileum (two cases), jejunum (one case) and the duodenum (one case). These data provide strong evidence that wireless capsule technology is significantly more accurate in evaluating the small intestine in patients with small intestine diseases.

"Our study confirms previous study findings that established the accuracy of innovative wireless capsule technology in identifying intestinal polyps," said Josep Llach, MD, lead study author from the Endoscopy Unit of the University of Barcelona in Spain. "This non-invasive procedure is legitimately setting a new standard for small bowel assessment."

A Prospective, Multicenter, Randomized, Single-Blind, Parallel Group Study on the Comparison Between Endoscopic Cardia Suturing and Sham Operation As a Treatment of Patients With Gastroesophageal Reflux Symptoms (Abstract 632)

Endoscopic gastric plication (EGP) is an outpatient procedure in which tissue in the lower esophagus is sewn together to provide protection from acid from the stomach. Researchers believe EGP is effective in reducing symptoms of GERD and the need for acid-reducing medications. In this multi-center study from Sweden, researchers aimed to find out whether the technique is effective for GERD patients, as compared to a standard sham procedure.

Forty-seven patients were randomized to receive either an EGP operation or sham operation and were treated with esomeprazole for two weeks following the operation. Having reported relapses in a daily electronic diary, most of the EGP patients (86 percent) and all of the sham operated patients experienced a relapse within the first year, indicating no significant difference in time of relapse between the groups. Thus EGP appeared to provide no clinical benefit in rates of relapse for GERD patients or reduction in use of acid-reducing medications. In addition, patient reports showed no significant difference in health-related quality of life.

"Our findings suggest endoscopic gastric plication is not as beneficial for GERD patients as previously thought," said Per-Ola Park, M.D., of Sahlgrenska University Hospital/Östra. "Instead of relying on what may be a costly and unnecessary procedure, GERD patients should continue using their current acid-reducing medications and work with their doctor to reduce symptoms in other helpful ways."

A Blinded, Randomized, Sham-Controlled Trial of Endoscopic Gastroplication for the Treatment of Gastro-Esophageal Reflux Disease (GERD): Preliminary Results (Abstract 496)

In an effort to evaluate the potential value of invasive procedures in GERD patients and conduct confirmatory trials, researchers from University Medical Center of Utrecht in the Netherlands conducted this trial to evaluate the effectiveness of the EndoCinch? suturing system. This outpatient procedure involves the stitching of tissue near the lower esophageal sphincter (LES) via a flexible tube placed in the esophagus. The study found the procedure reduced symptoms of GERD and the need for acid-reducing medications.

The study examined 45 patients with daily symptoms of GERD and grouped them into three categories: those who received the EndoCinch endoscopic procedure (15 patients), those who received a sham procedure (17 patients) and those who received only acid-reducing medication (13 patients). After three months, patients who received the EndoCinch procedure experienced neither a significant general improvement in quality of life nor a significant improvement in severity of regurgitation. Heartburn frequency and severity in this group did improve overall, and regurgitation frequency improved as well, but did not compare to the group who received the sham procedure. The EndoCinch procedure did not appear to reduce exposure to acid in the esophagus compared to the sham procedure.

"Endoscopic sutures are growing in popularity and our study confirmed that the procedure can indeed reduce GERD symptoms and the need for acid-reducing medications," said Matthijs P. Schwartz, M.D., lead study author from the University Medical Center of Utrecht. "But some of our findings call into question whether the procedure provides a significant benefit in reducing gastro-esophageal reflux. We are awaiting the final results of our study, but further studies are needed to establish the exact mechanisms of action of endoluminal suturing and to improve suturing techniques."

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Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 14-19, 2005 in Chicago, IL. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.


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