Introduction: Here we report the first human experience with an endoluminal, endoscopically delivered and retrieved gastro-duodeno-jejunal bypass sleeve (ValenTx, Inc. Carpinteria, CA), including the short-term weight loss and changes in co-morbidities.
Methods and Procedures: The gastro-duodeno-jejunal bypass sleeve (GJBS) is a 120cm sleeve secured at the esophago-gastric junction with endoscopic and laparoscopic techniques, and is designed to create an endoluminal gastro-duodeno-jejunal bypass. The patients are morbidly obese individuals who meet NIH criteria for bariatric surgery. A prospective, single-center, 12 week trial was designed. At the completion of this trial, the device was explanted with endoscopic retrieval. The primary endpoints were safety and incidence of adverse events. The secondary outcomes included the percentage of excess weight loss (EWL) and changes in co-morbidities, specifically glucose control, use of anti-hyperglycemics, and changes in hemoglobin A1C levels.
Results: From July 2008 until September 2009, 24 patients were enrolled. The device was implanted, left in-situ, and then retrieved. The study included 7 men and 17 women with a mean pre-operative BMI of 41.0 kg/m2. The GJBS was successfully delivered in 22 of the 24 patients (92%) and retrieved endoscopically in all 22 patients in whom it was implanted (100%). One patient was excluded pre-operatively secondary to failure to lose weight on the pre-op liquid diet. One device was not attempted endoscopically due to significant inflammation at the gastro-esophageal junction at the time of laparoscopic evaluation.
In the first phase of the study, 12 patients had the device placed. Nine of these patients maintained the device for the full 12 weeks of the study. These patients had 39.9% excess weight loss at the completion of the study. In the second phase of the trial, 12 patients were enrolled; at eight weeks the EWL is 40.5%.
Of the 22 patients with the device implanted, 17 have maintained it (77%). Nine patients completed the 12-week trial and eight are ongoing at 8 weeks. The primary reason for early explantation of the device was early post-operative dysphagia.
The seven patients with pre-operative diabetes mellitus all had normal blood glucose levels throughout the trial and none required anti-hyperglycemic medications. All seven patients with elevated Hemoglobin A1C levels pre-operatively showed improvement by the end of the trial.
Conclusions: This trial demonstrates that the endoluminal gastro-duodeno-jejunal bypass sleeve can achieve excellent weight loss at 12 weeks. No patient safety issues were encountered. Adverse effects were minimal and resolved upon endoscopic device removal. Effective glycemic control was demonstrated through use of the device during the trial. Long-term results are needed.
Session: Podium Presentation
Program Number: S041