Safety and efficacy of a new Endoscopic Duodenal-Jejunal Bypass Liner (DJBL) in morbidly obese subjects implanted for up to three years.

Nicolas Quezada1, Erick Castillo1, Rodrigo Munoz1, Fernando Pimentel1, Dannae Turiel1, Alex Escalona2, Palmenia Pizarro1. 1Pontificia Universidad Catolica de Chile, 2Universidad de Los Andes

Introduction: The duodenal-jejunal bypass liner (DJBL, EndoBarrier) is an endoscopic device that mimics the duodenal-jejunal exclusion of the Roux-en-Y gastric bypass. Previous reports have shown significant weight loss in morbidly obese patients and improvement in type 2 diabetes (T2DM) for up to one-year.

Aim: The aim of this study was to evaluate safety and efficacy in obese subjects implanted with a new (second generation (2G/Long-term)) DJBL for 1, 2 and 3 years.

Methods: Morbidly obese subjects were enrolled in a single arm, open label, prospective trial and implanted with the new DJBL (2G).Patients were annually offered to continue on trial and signed a new consent. Primary endpoint was safety with the use of the DJBL (2G). Secondary endpoints included weight change from baseline to 1, 2 and 3 years.

Results: The DJBL was implanted endoscopically in 80 of 81 subjects (age:35±9 y; 69% female; weight:109±17 kg; BMI:42.2±5.4 kg/m2), seventeen patients (21%) with type 2 diabetes. One subject could not be implanted due to unfavorable anatomy. Implantation and x-ray time were 30±18 min and 8±5 min, respectively.

Two patients presented a short esophageal perforation during explantation attempt at 52 and 104 weeks. These complications were successfully managed with endoscopic closure in one patient and medicaltreatment in the other one. Explant was performed 4 and 12 weeks later, respectively with no issues. Sixty eight patients (85%) presented any adverse event during the follow-up and 45 (56%) were admitted due to adverse events during the follow-up. There were 8(10%) early explants due to severe adverse events; liver abscess (3), upper GI bleeding (3), cholangitis (1), acute pancreatitis (1) mostly occurring during the second year. In the completer population at 52 week (71 patients), 104 (40 patients) and 156 weeks (10patients), mean weight was; 90±15, 91±16 and 93±13kg, respectively (p<0.0001), equivalent to 44±16, 40±22 and 39±20 %EWL (p<0.001).

Conclusion: This study shows a significant and sustained weight loss after 3 years of treatment with this new DJBL. Serious adverse events, mostly after the first year prevents the use of this new DJBL for more than one year.

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