Initial human experience with restrictive duodenal-jejunal bypass liner for treatment of morbid obesity

Abstract

Background The duodenal-jejunal bypass liner is an endoscopically placed and removable intestinal liner that creates a duodenal-jejunal bypass, leading to diabetes improvement and weight loss. The aim of the present study was to evaluate the clinical effects and safety of the duodenal-jejunal bypass liner combined with a restrictor orifice (flow restrictor). Methods The device was endoscopically implanted in 10 patients (body mass index 40.8 ± 4.0 kg/m 2) and removed after 12 weeks. Dilation of the restrictor orifice was performed as clinically indicated with a 6-, 8-, or 10-mm diameter through-the-scope balloon. The measured outcomes included the percentage of excess weight loss, total weight loss, adverse events, and gastric emptying (GE) at baseline, weeks 4 and 12 of implantation, and 3–5 months after device removal. GE was measured by scintigraphy at 1, 2, and 4 hours after implantation. Results The percentage of excess weight loss and total weight loss at explantation was 40% ± 3% (range 21–64%) and 16.7 ± 1.4 kg (range 12.0–26.0), respectively. The 4-hour GE was 98% ± 1% at baseline, 72% ± 6% at 4 weeks ( P = 0.001 versus baseline), and 84% ± 5% at 12 weeks ( P <.05 versus baseline). After explantation, the rate of GE returned to normal in 7 of 8 subjects, but remained slightly delayed in 1 subject (84% at 4 hours). Episodes of nausea, vomiting, and abdominal pain required endoscopic dilation of the restrictor orifice with a 6-mm through-the-scope balloon in 7 patients and a 10-mm balloon in 1, with no clinically significant adverse events. Conclusion Endoscopic implantation of a combination flow restrictor and duodenal-jejunal bypass liner induced substantial weight loss. The implanted patients exhibited delayed GE that was reversed after device removal.