Open-label, sham-controlled trial of an endoscopic duodenojejunal bypass liner for preoperative weight loss in bariatric surgery candidates.

BACKGROUND: The duodenojejunal bypass liner (DJBL) (EndoBarrier Gastrointestinal Liner) is an endoscopically placed and removable intestinal liner that creates a duodenojejunal bypass resulting in weight loss and improvement in type 2 diabetes mellitus. OBJECTIVE: Weight loss before bariatric surgery to decrease perioperative complications. DESIGN: Prospective, randomized, sham-controlled trial. SETTING: Multicenter, tertiary care, teaching hospitals. PATIENTS: Twenty-one obese subjects in the DJBL arm and 26 obese subjects in the sham arm composed the intent-to-treat population. INTERVENTIONS: The subjects in the sham arm underwent an EGD and mock implantation. Both groups received identical nutritional counseling. MAIN OUTCOME MEASUREMENTS: The primary endpoint was the difference in the percentage of excess weight loss (EWL) at week 12 between the 2 groups. Secondary endpoints were the percentage of subjects achieving 10% EWL, total weight change, and device safety. RESULTS: Thirteen DJBL arm subjects and 24 sham arm subjects completed the 12-week study. EWL was 11.9% +/- 1.4% and 2.7% +/- 2.0% for the DJBL and sham arms, respectively (P < .05). In the DJBL arm, 62% achieved 10% or more EWL compared with 17% of the subjects in the sham arm (P < .05). Total weight change in the DJBL arm was -8.2 +/- 1.3 kg compared with -2.1 +/- 1.1 kg in the sham arm (P < .05). Eight DJBL subjects terminated early because of GI bleeding (n = 3), abdominal pain (n = 2), nausea and vomiting (n = 2), and an unrelated preexisting illness (n = 1). None had further clinical symptoms after DJBL explantation. LIMITATIONS: Study personnel were not blinded. There was a lack of data on caloric intake. CONCLUSIONS: The DJBL achieved endoscopic duodenal exclusion and promoted significant weight loss beyond a minimal sham effect in candidates for bariatric surgery. ( CLINICAL TRIAL REGISTRATION NUMBER: NPT00469391.).

The ERCP quality network: a pilot study of benchmarking practice and performance.

There is increasing interest in the quality of endoscopic practice and in documenting it. Endoscopic retrograde cholangiopancreatography (ERCP) is the most complex and risky procedure performed regularly by gastroenterologists. The goal was to test the acceptability and functioning of a voluntary system for individual endoscopists to report details of their ERCP cases and to compare them with unidentified peers. Participants were compared by site of practice, procedure complexity, volumes, durations, and selected technical success rates. There was no independent audit. A total of 63 endoscopists in the United States entered data on 18 182 procedures over 3 years. Results in academic and community practices were similar, but there were significant and expected differences in the complexity of practice and key quality metrics between endoscopists performing more than and fewer than 100 cases per year. The study provided useful data on variations in ERCP practice in the United States and will assist in planning the development of national projects in this field.

Duodenal- jejunal bypass sleeve: a totally endoscopic device for the treatment of morbid obesity.

Morbid obesity affects over 15 million people in the United States. Nonsurgical management produces sustained weight loss in less than 5% of patients. Despite associated comorbidities, less than 1% of obese patients seek surgical intervention. Less invasive procedures have been developed with varying success. The Endobarrier( trade mark) (GI Dynamics(trade mark), Watertown, MA) duodenal-jejunal bypass sleeve is a totally endoscopically delivered device designed to produce weight loss in the morbidly obese. We describe the first placement of a duodenal-jejunal bypass sleeve in a patient in the United States. A blinded, randomized, prospective clinical trial was approved by the Food and Drug Administration to evaluate safety and efficacy of a novel device for weight loss in the obese. The first patient enrolled was a 36-year-old woman with body mass index of 45.2. After informed consent, endoscopic placement of the device under general anesthesia was performed using fluoroscopy to confirm positioning. The device was placed without complications. At conclusion of the 3-month study period, the device was removed endoscopically. Total weight lost by the patient was 9.09 kg. Described herein is the first deployment of the duodenal-jejunal bypass sleeve in North America. The device is delivered in a totally endoscopic manner in morbidly obese patients. In our patient, total weight loss at 3 months was 9.09 kg. Continued follow-up and enrollment is ongoing to demonstrate patient safety and efficacy. Additional studies are being performed to elucidate mechanism of weight loss and future clinical applications of this device.