Dig Endosc. 2022 Jul 23. doi: 10.1111/den.14409. Online ahead of print.
OBJECTIVES: To evaluate the safety and efficacy of a new endoscopic duodenal-jejunal bypass sleeve (DJBS) in obese patients with non-alcoholic fatty liver disease (NAFLD), while in situ for 3 months, and at 6 months post-explantation.
METHODS: Patients with obesity and NAFLD were enrolled in this single-center, prospective study, wherein TONGEE® DJBS was implanted for 3 months. Primary outcomes were weight loss and changes in hepatic steatosis. Secondary outcomes included changes in liver enzymes, glycemic control, and lipid profile and device safety.
RESULTS: Twenty-six patients (age: 35.2 ± 7.2 years; 61.5% women) underwent DJBS implantation. At 3 months, body weight change from baseline was -8.0 ± 3.6 kg (P < 0.001), corresponding to 8.9 ± 4.0% of total body weight. Hepatic steatosis significantly improved based on controlled attenuation parameter, hepatic steatosis index, and fatty liver index (P < 0.001). Liver enzymes, insulin resistance, and metabolic parameters were also improved. At 6 months post-explantation, weight loss and improvements in hepatic steatosis and liver enzyme levels remained statistically significant. Only one patient had a serious adverse event, namely, upper gastrointestinal hemorrhage.
CONCLUSIONS: Three-month TONGEE® DJBS implantation resulted in significant weight loss and improvement in hepatic steatosis, liver enzymes, insulin resistance, and metabolic parameters in obese patients with NAFLD. Randomized controlled trials are required to further elucidate these initial findings.