Implantable endoscopic gastric bypass - device and experimental procedure

Abstract

Malabsorptive bariatric surgery is an effective treatment option for morbid obesity, but may be associated with complications and side effects. We have developed a new experimental approach to creating a gastric bypass through an intraluminal access. The goal is to reduce postoperative complications and to reduce mid-term side-effects of malabsorptive bypass food passage and to allow easy reversion of the procedure. The new procedure is based on an implantable gastric bypass device, installed by combined transoral flexible and minimally invasive abdominal access. The newly developed device and procedure were studied in a pilot experimental trial in the porcine animal model (n=8). Endpoints were the feasibility of the technical procedure, the ability of the animal to eat and digest food, the implant functionality over the survival period and the absence of major complications over a short-term follow-up (one week). The procedure was technically successful in all eight animals. Animals were able to take in food and water till sacrifice. Four animals had major complications (one abdominal wall dehiscence, one invagination ileus of the small bowel, one dehiscence of the gastro-jejunal anastomosis and one myocardial infarction) and did not complete follow-up. In two cases migration of the device into the stomach was observed. The difference between our experimental technique and the gold standard surgical methods for gastric bypass consists of the endoluminal approach by implanting an intraluminal gastric bypass device. This concept avoids gastric transsection and an additional anastomosis and enables an adjustable food passage between the bypass and the natural duodenal passage. Further long-term follow-up studies are required.