Can a Duodenal-Jejunal Sleeve Device Induce Short-Term Weight Loss? Open Label, Prospective, Randomized Controlled Trial of an Endoscopic Duodenal-Jejunal Bypass Sleeve Versus Low Calorie Diet For Pre-Operative Weight Loss In Bariatric Surgery

Background: A new endoscopically and fluoroscopically placed duodenal-jejunal bypass device developed for weight loss is a 60cm flouropolymer sheath, which expands and anchors in the duodenal bulb via barbs. A prior small uncontrolled trial found short-term weight loss in obese recipients. Objective: To test the duodenal-jejunal sleeve in a randomized controlled trial. Design: Open label, claimed randomized, small, non-blinded controlled clinical trial . Participants: 39 subjects who planned to undergo bariatric surgery and needed pre-operative weight loss. Methods: Selected subjects underwent endoscopic placement of the device. Controls did not receive the device. Both groups underwent baseline counseling regarding diet, exercise, and behavior modification. Primary end-point was percentage of excess weight lost at 12 weeks. Results: Sleeve insertion was attempted in 26 subjects, but was successful only in 25. Of subjects, 14 were assigned to the control group. Only half of the endoscopic sleeve subjects appear to have been randomized and the other half were assigned directly. At 12 weeks, 20 device recipients completed the protocol and achieved a statistically significant mean percentage excessive weight loss of 22.1±8% compared with only 5.3±6.6% (P =0.02) in the 4 controls who completed the study. Of subjects, 92% of implanted patients and 21% of controls achieved ≥10% excess weight loss reduction a significant difference. All sleeves were removed successfully at 12 weeks. There was no evidence of pancreatic-biliary obstruction. The sleeve was removed early in 5 patients 3 for GI bleeding, 1 for anchor migration, and 1 for sleeve obstruction. Conclusions: The authors conclude that the duodenal-jejunal bypass sleeve appears to be effective for shortterm weight loss. They note that longer-term sham controlled trials are underway. Reviewer's Comments: The authors note the long learning curve for sleeve deployment. They suggest that the success of the sleeve may be due to the transient abdominal pain and increased satiety produced in many. This trial is a high-risk of bias, low methodological quality trial. High risk-of-bias trials generally find more beneficial outcomes. Methodological deficiencies in this trial include: 1) although claimed to be randomized, it was not; many of the sleeve recipients were assigned to that group directly, for non-described reasons; 2) there was no documentation of concealed allocation; 3) it was not blinded; 4) there was no power or sample size calculation; 5) not all subjects were included in the analysis just those who completed the trial, making the analysis "per protocol" rather than intention-to-treat. Finally, by not providing any assistance to the diet control group other than a base-line consultation, the authors set up a control group that was bound to fail. (Reviewer-Timothy O. Lipman, MD).