Endoscopic gastric volume reduction with a novel articulating plication device is safe and effective in the treatment of obesity (with video).

BACKGROUND: Endoscopic volume reduction of the stomach may provide a minimally invasive alternative for surgical procedures in the treatment of obesity. OBJECTIVE: To assess safety and preliminary effectiveness in the first human application of a novel endoscopic stapling technique. DESIGN: Prospective, observational, phase 1 study. SETTING: Two university hospitals in The Netherlands. PATIENTS: Patients with a body mass index (BMI) of 40 to 45 kg/m(2) or 30 to 39.9 kg/m(2) with obesity-related comorbidity. INTERVENTIONS: Gastric volume reduction with an endoscopic stapler. MAIN OUTCOME MEASUREMENTS: Primary outcome measure was the prevalence of serious or mild adverse events. Reduction of excess body weight after 12 months was assessed as a secondary outcome measure for effectiveness of the procedure. RESULTS: Seventeen patients with a median BMI of 40.2 kg/m(2) (interquartile range [IQR] 37.6-42.8) underwent an endoscopic stapling procedure. Median procedure time was 123 minutes (IQR 95-129). No serious adverse events occurred. Adverse events were gastric pain (n = 7, range 1-3 days), sore throat (n = 4, 2-3 days), diarrhea (n = 4, 2-15 days), nausea (n = 3, 2-4 days), constipation (n = 4, 3-14 days), and vomiting (n = 3, 1-4 days). All adverse events were mild and resolved with conservative treatment within 15 days after surgery. The median percentage excess weight loss in the first year was 34.9% (IQR 17.8-46.6). LIMITATIONS: Limited number of patients. CONCLUSION: This first human application of this endoscopic stapler demonstrates that the procedure is technically feasible and safe. One hundred sixty plications were created in 17 patients without significant problems. Weight loss after 1 year is promising, but long-term follow-up and randomized, controlled studies should evaluate whether this procedure is an effective and durable minimally invasive endoscopic treatment for obesity. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01429194.).

Short-term safety and efficacy of the Trans-oral Endoscopic Restrictive Implant System for the treatment of obesity.

BACKGROUND: Medical treatment of obesity often fails, and surgical treatment, although successful, is aggressive. OBJECTIVE: To evaluate the short-term safety and efficacy of an endoscopic restrictive implant procedure in the treatment of obesity. DESIGN: Prospective, observational study. SETTING: Tertiary-care referral hospital in The Netherlands. PATIENTS: This study involved 13 patients with body mass indexes of between 40 and 50 kg/m(2) or between 35 and 40 kg/m(2) with obesity-related comorbidities. INTERVENTION: A new transoral endoscopic restrictive implant procedure in the treatment of obesity. MAIN OUTCOME MEASUREMENTS: Safety of the procedure, percentage of excess weight loss, change in body mass index. RESULTS: In 1 patient, the procedure was abandoned after a gastric perforation related to stapler malfunctioning. In 2 patients, pneumoperitoneum was detected. This was desufflated with a percutaneous hollow needle in one patient and treated conservatively in the other. After these complications, technical adjustments were made in the procedure, and no subsequent procedural complications were seen. At 3 months postprocedure, patients obtained a median excess weight loss of 28%. Median body mass index decreased from 42.1 to 37.9 kg/m(2). LIMITATIONS: Small number of patients. CONCLUSION: Preliminary results of this transoral endoscopic restrictive implant system for the treatment of obesity showed successful placement in 12 of 13 patients. Procedural complications occurred in 3 patients. Weight loss was comparable to that of laparoscopic gastric band placement. Further long-term studies are under way.