Endoluminal Tactics May Cut Bariatric Morbidity
Such suturing procedures hold particular promise, Dr. Schauer said, because “they emulate gastric restriction, a concept that has been proven over several decades in bariatric surgery.”
Dr. Schauer is one of the clinicians participating in the phase III RESTORe (Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction) trial for patients with inadequate weight loss following RYGB.
The purpose of the trial, which is supported by Bard and Davol Inc., is to evaluate weight loss and other clinical outcomes following application of transoral reduction of a dilated gastrojejunostomy anastomosis in 220 patients who have not achieved adequate weight loss following RYGB. The expected completion date of the trial is July 2008.
The use of endoluminal techniques for the primary treatment of obesity is in its infancy, Dr. Schauer said. One investigational device that has been studied in small trials of patients outside the United States is the transoral gastroplasty (TOGa) system, developed by Satiety Inc. In this procedure, an endoscopic stapling device is inserted through the mouth to the stomach to create a small restrictive pouch.
Dr. Gagner said that he is optimistic about such developments but cautioned that much more study is required before they are embraced by gastrointestinal endoscopic surgeons.
“It's great that we have this research effort going on, that there's a lot of enthusiasm,” he said. “People think it's going to happen overnight. I think it's going to take much longer than what we think.”
Dr. Schauer called the development of endoluminal techniques for obesity “another potential great leap forward in reducing the risk of these procedures. We already know that going from open procedures to laparoscopic procedures was one of the major factors that propelled bariatric surgery from a very low niche field [15,000 cases per year] across the United States, to 200,000 procedures per year. What really drove that was the reduction in complications and recovery.”
Similar success with endoluminal techniques will take time, and will require the ability to overcome technical hurdles and challenges associated with reimbursement. “These procedures will require new CPT codes and applications to insurance carriers to get reimbursed,” he said.
Dr. Schauer disclosed that he is a paid consultant for Bard, Davol, Ethicon Endo-Surgery Inc., Stryker Endoscopy, Baxter International Inc., W.L. Gore & Associates Inc., and Barosense Inc.
Dr. Gagner disclosed that he is a scientific adviser for GI Dynamics Inc. He also has received research grants from Covidien AG, Olympus America Inc., and Bard.
'We might be able to change some of the GI hormones that may switch the diabetes to reverse itself.' DR. GAGNER
