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Minimal Benefit for EndoCinch Suturing in Gastroesophageal Reflux Disorder

By W. A. Thomasson, PhD

CHICAGO, IL -- May 16, 2005 -- Only minimal benefit is derived from treating gastroesophageal reflux disorder (GERD) with endoscopic gastroplication using the EndoCinch(TM) system, according to findings from 2 randomized controlled trials presented here May 15^th at Digestive Disease Week (DDW).

"I think probably we should stop doing this procedure because it's not good enough, and wait until it's improved and then go on," said the lead author of 1 of the studies, Matthijs Schwartz, MD, director of endoscopy, University Medical Center Utrecht, Utrecht, The Netherlands, during a press conference.

The lead author of the second paper, Per-Ola Park, MD, gastroenterologist, Sahlgranska University Hospital/Ostra, Goteborg, Sweden, agreed with Dr. Schwartz and offered several suggestions for possible approaches to improvement.

The procedure involves suturing to create a pleat just below the lower esophageal sphincter. Uncontrolled trials have suggested the procedure is effective in reducing reflux from the stomach and symptoms of chronic heartburn.

In both studies, to be formally presented at the conference on May 17^th, researchers randomized patients either to gastroplication or to a sham operation in which heavily sedated patients received cues indistinguishable from those of the real procedure.

Dr. Schwartz's study also had an observation arm in which patients continued on their usual proton-pump inhibitor therapy without surgery.

Dr. Park's study enrolled 47 patients who were followed for 1 year after the procedure. Most relapsed within 1 month, he said; by the end of the year 86% of 22 EndoCinch and 100% of 25 sham-operated patients had relapsed. At the end of the year there were no significant differences between the 2 groups in 24-hour esophageal pH, health-related quality of life, or number of proton-pump inhibitor pills taken since relapse.

Dr. Schwartz's study enrolled 45 patients, with preliminary data being reported after 3 months. In this study, use of proton-pump inhibitors was significantly reduced by 60% from baseline compared with14% with the sham operation. There was also a significant reduction in heartburn score compared with either sham operation or observation groups. Real and sham operations reduced the regurgitation score and the 24-hour esophageal pH to approximately the same extent.

In a prepared statement, Dr. Park concluded, "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."

Dr. Park received support for his study from AstraZeneca and Bard.


[Presentation titles: A Prospective, Multicenter, Randomized, Single-Blind Parallel Group Study on the Comparison Between Endoscopic Cardia Suturing and Sham Operation at a Treatment of Patients With Gastroesophageal Reflux Symptoms. Abstract 632. A Blinded, Randomized, Sham-Controlled Trial of Endoscopic Gastroplication for the Treatment of Gastro-Esophageal Reflux Disease (GERD): Preliminary Results. Abstract 496]

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