Safety and efficacy of the endoscopic duodenal–jejunal bypass liner prototype in severe or morbidly obese subjects implanted for up to 3 years Nicola ´s Quezada 1 • Rodrigo Mun ˜oz 1 • Carla Morelli 1 • Dannae Turiel 1 • Julia ´n Herna ´ndez 1 • Fernando Pimentel 1 • Alex Escalona 2 Received: 16 May 2016 / Accepted: 13 June 2017 Ó Springer Science+Business Media, LLC 2017 Abstract Background The duodenal–jejunal bypass liner (DJBL) is an endoscopic device that mimics the duodenal–jejunal exclusion component of the Roux-en-Y gastric bypass. Previous studies assessing the efficacy of the DJBL have shown 10-40% excess weight loss (%EWL) and improve- ments in obesity-associated comorbidities. The aim of this study was to evaluate the safety and efficacy of a new DJBL prototype over a 3-year period. Methods Morbidly obese subjects were enrolled in a sin- gle-arm, open-label, prospective trial. The subjects were offered the opportunity to continue with the trial annually and signed a new consent form. The primary endpoint was safety. The secondary endpoints were changes in weight and biochemical parameters from baseline. Results The DJBL was implanted endoscopically in 80 subjects (age: 35±10 years; 69% female; weight: 109±17 kg; BMI: 42±5.4 kg/m 2 ). Seventy-two severe adverse events (AEs) were observed in 55 patients (68%), of which nine subjects required a prolonged hospital stay and three subjects required major interventions. Overall, 23 subjects (29%) underwent early device removal due to AEs. Additionally, 95% of the patients experienced mild AEs that mainly consisted of abdominal pain. The severe AEs included a liver abscess (3), upper GI bleeding (4), cholangitis (1), and acute pancreatitis (1) and mostly occurred after 12 months of follow-up. Two patients pre- sented a short esophageal perforation during explantation. These perforations were successfully managed with endo- scopic closure in one subject and medical treatment in the other subject. In the completer population at 52 weeks (71 patients), 104 weeks (40 patients), and 156 weeks (11 patients), the mean %EWL were 44 ± 16, 40 ± 22, and 39 ± 20, respectively (p \ 0.001). Conclusion This study shows significant and sustained weight loss after 3 years of treatment with the new DJBL. However, the high frequency and severity of AEs preclude the use of this prototype for periods longer than 1 year. Keywords Obesity Á Endobarrier Á Bariatric Á Endoscopy Obesity deteriorates the quality of life and decreases the life expectancy due to its association with several chronic diseases, including type 2 diabetes mellitus (T2DM), dys- lipidemia, arterial hypertension, cancer, joint diseases, and cardiovascular disease, among others [1, 2]. Approximately 97 million individuals have been estimated to be affected by problems associated with overweight or obesity in the United States. In developing countries such as Chile, studies have shown that overweight and obesity affect 39.3 and 25.1% of adults, respectively. Currently, bariatric surgery has been shown to be the most effective intervention for the treatment of obesity and most of its associated diseases. Among the different available surgical procedures for weight loss, sleeve gas- trectomy (SG) and the Roux-en-Y gastric bypass (RYGB) Presented at the SAGES 2016 Annual Meeting, March 16–19, 2016, Boston, Massachusetts. Electronic supplementary material The online version of this article (doi:10.1007/s00464-017-5672-0) contains supplementary material, which is available to authorized users. & Nicola ´s Quezada nfquezada@gmail.com 1 Department of Digestive Surgery, School of Medicine Pontificia Universidad Cato ´lica de Chile, Diagonal Paraguay 362, Cuarto Piso, Santiago, Chile 2 Universidad de los Andes, Santiago, Chile 123 Surg Endosc DOI 10.1007/s00464-017-5672-0 and Other Interventional Techniques