Safety and Effectiveness of an Endoscopically Placed Duodenal-Jejunal Bypass Device (EndoBarrier®): Outcomes in 114 Patients

• Published in: Obesity surgery Vol. 27; no. 12; pp. 3306 - 3313
• Main Authors: Forner, Patrice M., Ramacciotti, Timothy, Farey, John E., Lord, Reginald V.
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.12.2017; Springer Nature B.V
• Subjects: Adult; Blood Glucose - metabolism; Device Removal; Diabetes; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - surgery; Duodenoscopy - adverse effects; Duodenoscopy - instrumentation; Duodenoscopy - methods; Duodenum - surgery; Endoscopy; Equipment Safety; Female; Gastric Bypass - adverse effects; Gastric Bypass - instrumentation; Gastric Bypass - methods; Gastrointestinal surgery; Humans; Insulin - blood; Jejunum - surgery; Male; Medicine; Medicine & Public Health; Middle Aged; New Concept; Obesity; Obesity, Morbid - blood; Obesity, Morbid - complications; Obesity, Morbid - surgery; Patient safety; Prostheses and Implants - adverse effects; Retrospective Studies; Surgery; Surgical outcomes; Treatment Outcome; Weight control; Weight Loss; Obesity; Endoscopy; Bariatric; Diabetes mellitus
• ISSN: 0960-8923; 1708-0428
• DOI: 10.1007/s11695-017-2939-4

Background The duodenal-jejunal bypass liner (DJBL) is an endoscopically placed device designed to achieve weight loss and improve glycemic control in obese patients. Previous studies report promising results but typically included small patient numbers and short follow-up. This study aims to determine the safety and effectiveness of the device. Methods Study design: A series of all patients treated by the DJBL at our institutions. Outcome measurements: Weight loss, biochemical measures, complications. Results Between July 2012 and March 2015, 114 consecutive patients were treated for a mean 51.1 weeks (standard deviation (SD) 19.9 weeks). Mean total body weight change from baseline was 12.0 kg (SD 8.5 kg, p  < 0.001). Mean percent total body weight loss (%TWL) was 10.5% (SD 7.3%). Mean HbA1c was not significantly improved, but of 10 patients on insulin, 4 ceased insulin and 4 reduced insulin dosages. There was a significant decrease in hemoglobin and total cholesterol and a significant increase in serum alkaline phosphatase. Seventy-four percent of patients experienced at least one adverse event, some of them serious including 6 device obstructions, 5 gastrointestinal hemorrhages, 2 liver abscesses, and 1 acute pancreatitis. Seventy-four percent of patients experienced weight gain after removal with a mean 4.5 ± 6.1 kg ( p  < 0.0001) within the first 6 months after explantation. Conclusions The DJBL provides significant but highly variable weight loss. Glycemic control was variable. Most insulin-requiring T2DM patients ceased or reduced insulin. Most patients experience an adverse event and most regain significant weight after device removal. Major adverse events can occur, including the potentially life-threatening complications of hepatic abscess and gastrointestinal hemorrhage.