Schouten et al (2010) noted that the endoscopically placed duodenal-jejunal bypass sleeve or EndoBarrier Gastrointestinal Liner has been designed to achieve weight loss in morbidly obese patients. A multi-center, randomized clinical trial was performed. A total of 41 patients were included and 30 underwent sleeve implantation; 11 patients served as a diet control group. All patients followed the same low-calorie diet during the study period. The purpose of the study was to determine the safety and effectiveness of the device. A total of 26 devices were successfully implanted. In 4 patients, implantation could not be achieved. Four devices were explanted prior to the initial protocol end point because of migration (n = 1), dislocation of the anchor (n = 1), sleeve obstruction (n = 1), and continuous epigastric pain (n = 1). Mean procedure time was 35 mins (range of 12 to 102) for a successful implantation and 17 mins (range of 5 to 99) for explantation. There were no procedure related adverse events. During the study period the 26 duodenal-jejunal bypass sleeve patients (100 %) had at least 1 adverse event, mainly abdominal pain and nausea during the first week after implantation. Initial mean BMI was 48.9 and 47.4 kg/m2 for the device and control patients, respectively. 0 % for device patients versus 6.9 % for control patients (p < 0.002). Absolute change in BMI at 3 months was 5.5 and 1.9 kg/m2, respectively. Type 2 diabetes mellitus was present at baseline in 8 patients of the device group and improved in 7 patients during the study period (lower glucose levels, glycated hemoglobin [HbA1c], and medication requirements). The authors concluded that the EndoBarrier Gastrointestinal Liner is a feasible and safe non-invasive device with excellent short-term weight loss results. The device also has a significant positive effect on type 2 diabetes mellitus. Moreover, they stated that long-term randomized and sham studies for weight loss and treatment of diabetes are necessary to determine the role of the device in the treatment of morbid obesity.
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Escalona et al (2012) evaluated safety, weight loss, and cardio-metabolic changes in obese subjects implanted with the DJBL for 1 year. Morbidly obese subjects were enrolled in a single-arm, open-label, prospective trial and implanted with the DJBL. Primary endpoints included safety and weight change from baseline to week 52. Secondary endpoints included changes in waist circumference, blood pressure, lipids, glycemic control, and metabolic syndrome. The DJBL was implanted endoscopically in 39 of 42 subjects (mean age of 36 +/- 10 years; 80 % female; mean weight of 109 +/- 18 kg; mean BMI of 43.7 +/- 5.9 kg/m); 24 completed 52 weeks of follow-up. Three subjects could not be implanted due to short duodenal bulb. Implantation time was 24 +/- 2 mins. There were no procedure-related complications and there were 15 early endoscopic removals. In the 52-week completer population, total body weight change from baseline was -22.1 +/- 2.1 kg (p < 0.0001) corresponding to 19.9 +/- 1.8 % of total body weight and 47.0 +/- 4.4 % excess of weight loss. There were also significant improvements in waist circumference, blood pressure, total and low-density lipoprotein cholesterol, triglycerides, and fasting glucose. The authors concluded that the DJBL is safe when implanted for 1 year, and results in significant weight loss and improvements in cardio-metabolic risk factors. They stated that these results suggested that this device may be suitable for the treatment of morbid obesity and its related comorbidities. Main drawbacks of this study were its small sample size and only 24 of 39 subjects (62 %) completed the 52-week followed-up.