ORLANDO – Endoscopic placement of a gastric-jejunal bypass sleeve led to significant weight loss and improvements in diabetes and other comorbidities in a pilot study with 24 patients who had the sleeve in place for up to 1 year.
Endoscopic insertion of the bypass sleeve in these 24 patients involved laparoscopic assistance. Future refinements may eliminate the laparoscopic step and permit a fully nonsurgical approach to gastric bypass, Dr. Bryan J. Sandler said at the American Society for Metabolic and Bariatric Surgery annual meeting. Further study is needed to determine the experience with a larger number of patients and to examine their experience over time, added Dr. Sandler, a bariatric surgeon at the University of California, San Diego.
"It’s a really exciting technology," commented Dr. Aurora D. Pryor, a surgeon in the Center for Metabolic and Weight Loss Surgery at Duke University in Durham, N.C. "It potentially expands the kind of patient in whom you could use this treatment, including bigger, high-risk patients, and possibly also patients with diabetes and a lower body mass index. I would like to see longer-term studies and have them see if they can still successfully exchange the sleeve, but if they can do it successfully long term, then it would be a very innovative solution," she said in an interview.
The study included 24 patients who averaged 40 years old, 71% of whom were women, with an average body mass index of 42 kg/m2, with a range of 35-51 kg/m2. Twelve patients received a bypass sleeve with a planned explant time of 3 months, and another 12 patients received a sleeve with planned explant time of 12 months. The researchers treated patients at San José Hospital Tec de Monterrey (Mexico).
The surgeons placed the top end of the polyurethane sleeve at the gastroesophageal junction and the bottom end into the jejunum, so that food bypassed most of the stomach and duodenum. The sleeve both restricts food intake and works as a food bypass, mimicking the effect of a surgical Roux-en-Y gastric bypass, Dr. Sandler said.
Among the 12 patients scheduled to have the sleeve in place for 3 months, three required faster removal; two for intolerable nausea and a third because the sleeve returned to the stomach. Among 12 other patients scheduled to have the sleeve in place for 12 months, two required faster removal; one because of nausea and a second because the sleeve returned to the stomach. There were no other serious adverse events, including no perforations, leaks, erosions, ulcerations, obstructions, peritonitis, or pancreatitis. The other 19 patients had their sleeves removed at the scheduled time, a consistently easy process with no indication of attachments formed, he said.
After 3 months, patients lost an average of 39% of their excess weight; at 9 months, they lost an average of 42% of their excess weight.
Eight of the 24 patients who entered the study had diabetes, with an average baseline hemoglobin A1c of 8.3%, and an average fasting plasma glucose of 152 mg/dL. After 3 months, all eight had improved, and four had complete resolution of their diabetes while off of all medications. Four of these patients had the sleeve in place for 12 months, and after 9 months all four showed improvement, with three having complete resolution of their diabetes.
Dr. Sandler reported similar response patterns for other comorbidities. For example, the study group included 11 patients with hypertension at baseline, and after 3 months, 8 of the 11 were normotensive. Seven of the hypertensive patients kept their sleeves for 12 months, and when their blood pressures were measured after 9 months, five of the seven were normotensive.
The study was funded by ValenTx, the company developing the bypass sleeve. Dr. Sandler said that he has been a consultant to ValenTx. Dr. Pryor said that she has been a consultant to Covidien, Olympus, and W.L. Gore, and she has an ownership interest in TransEnterix.