Authors: Bryan J Sandler Roberto Rumbaut C Paul Swain Gustavo Torres Luis Morales Lizcelly Gonzales Sarah Schultz Mark Talamini Santiago Horgan
Publish Date: 2011/04/13
Volume: 25, Issue: 9, Pages: 3028-3033
Abstract
A prospective singlecenter trial was designed The patients were morbidly obese individuals who met the National Institutes of Health criteria for bariatric surgery The device used was a unique gastroduodenojejunal bypass sleeve secured at the esophagogastric junction with endoscopic and laparoscopic techniques and designed to create an endoluminal gastroduodenojejunal bypass At completion of the trial the device was explanted with endoscopic retrieval The primary end points were safety and incidence of adverse events The secondary outcomes included the percentage of excess weight loss and changes in comorbidities specifically glucose control use of antihyperglycemic medications and changes in hemoglobin A1c levelsFrom July 2008 to February 2010 24 patients were enrolled in the trial The gastroduodenojejunal bypass sleeve was implanted left in situ and then retrieved The 7 men and 17 women in the study had a mean preoperative body mass index of 42 kg/m2 The device was successfully delivered in 22 of the 24 patients 92 and retrieved endoscopically from all 22 patients in whom it was implanted 100 Two patients were excluded from the study preprocedurally The one patient was excluded preoperatively due to noncompliance with the preoperative liquid diet For the other excluded patient the device was not attempted endoscopically due to significant inflammation at the gastroesophageal junction at the time of laparoscopic evaluation Of the 22 patients who had the device implanted 17 maintained it 77 and completed the full 12week trial These patients had 397 excess weight loss at completion of the study The primary reason for early explantation of the device was early postoperative dysphagia The seven patients with preoperative diabetes mellitus all had normal blood glucose levels throughout the trial and none required antihyperglycemic medications All four patients with elevated hemoglobin A1c levels preoperatively showed improvement by the end of the trialThis trial demonstrated that the endoluminal gastroduodenojejunal sleeve can achieve excellent weight loss at 12 weeks No patient safety issues were encountered Adverse effects were minimal and resolved at endoscopic device removal Effective glycemic control was demonstrated through use of the device during the trial Longterm results are neededBryan J Sandler Roberto Rumbaut Gustavo Torres Luis Morales and Lizcelly Gonzales have served as consultants for ValenTx Corporation Santiago Horgan and C Paul Swain have served as consultants for and have an equity interest in ValenTx Corporation Sarah Schultz and Mark Talamini have no conflicts of interest or financial ties to disclose
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