First human experience with endoscopically delivered and retrieved duodenal-jejunal bypass sleeve.

BACKGROUND: We report the first human experience with an endoscopic duodenal-jejunal bypass sleeve (DJBS) in a community hospital.
METHODS: The DJBS is a 60-cm sleeve anchored in the duodenum to create a duodenal-jejunal bypass. In a 12-patient prospective, open-label, single-center, 12-week study, the device was endoscopically implanted, left in situ, and retrieved. The study included 5 men and 7 women, with a mean body mass index of 43 kg/m(2). Of the 12 patients, 4 had type 2 diabetes. The primary endpoints were the incidence and severity of adverse events. The secondary outcomes included the percentage of excess weight loss and changes in co-morbid status.
RESULTS: The DJBS was endoscopically delivered and retrieved in all patients (mean implant/explant time of 26.6 and 43.3 min, respectively). Of the 12 patients, 10 were able to maintain the device for 12 weeks and 2 underwent explantation after 9 days secondary to poor device placement. Several self-limited adverse events were possibly or definitely related to the device, including 6 episodes of abdominal pain, 18 of nausea, and 16 of vomiting, mainly within 2 weeks of implantation. Two partial pharyngeal tears occurred during explantation. Implant site inflammation was encountered in all patients. No device-related event was considered severe. The average percentage of excess weight loss for the 10 patients with the device in place for 12 weeks was 23.6%, with all patients achieving at least 10% excess weight loss. All 4 diabetic patients had normal fasting plasma glucose levels without hypoglycemic medication for the entire 12 weeks. Of these 4 patients, 3 had decreased hemoglobin A(1c) of > or =.5% by week 12.
CONCLUSION: The DJBS can be safely delivered and removed endoscopically and left in situ for 12 weeks. The device had a favorable safety and encouraging efficacy profile. Randomized prospective trials are warranted.