Open-label, sham-controlled trial of an endoscopic duodenojejunal bypass liner for preoperative weight loss in bariatric surgery candidates

BackgroundThe duodenojejunal bypass liner (DJBL) (EndoBarrier Gastrointestinal Liner) is an endoscopically placed and removable intestinal liner that creates a duodenojejunal bypass resulting in weight loss and improvement in type 2 diabetes mellitus.ObjectiveWeight loss before bariatric surgery to decrease perioperative complications.DesignProspective, randomized, sham-controlled trial.SettingMulticenter, tertiary care, teaching hospitals.PatientsTwenty-one obese subjects in the DJBL arm and 26 obese subjects in the sham arm composed the intent-to-treat population.InterventionsThe subjects in the sham arm underwent an EGD and mock implantation. Both groups received identical nutritional counseling.Main Outcome MeasurementsThe primary endpoint was the difference in the percentage of excess weight loss (EWL) at week 12 between the 2 groups. Secondary endpoints were the percentage of subjects achieving 10% EWL, total weight change, and device safety.ResultsThirteen DJBL arm subjects and 24 sham arm subjects completed the 12-week study. EWL was 11.9% ± 1.4% and 2.7% ± 2.0% for the DJBL and sham arms, respectively (P < .05). In the DJBL arm, 62% achieved 10% or more EWL compared with 17% of the subjects in the sham arm (P < .05). Total weight change in the DJBL arm was −8.2 ± 1.3 kg compared with −2.1 ± 1.1 kg in the sham arm (P < .05). Eight DJBL subjects terminated early because of GI bleeding (n = 3), abdominal pain (n = 2), nausea and vomiting (n = 2), and an unrelated preexisting illness (n = 1). None had further clinical symptoms after DJBL explantation.LimitationsStudy personnel were not blinded. There was a lack of data on caloric intake.ConclusionsThe DJBL achieved endoscopic duodenal exclusion and promoted significant weight loss beyond a minimal sham effect in candidates for bariatric surgery. (Clinical trial registration number:NPT00469391.)