Safety experience with the duodenal-jejunal bypass liner: an endoscopic treatment for diabetes and obesity.
Słowa kluczowe
Abstrakcyjny
BACKGROUND
The duodenal-jejunal bypass liner (DJBL) is a new, device-based endoscopic treatment for type 2 diabetes mellitus (T2DM) and obesity.
OBJECTIVE
To report serious safety events of subjects treated with the DJBL while offering a simple guideline to mitigate risk.
METHODS
Single-center observational study.
METHODS
Tertiary referral center.
METHODS
For commercial use, patients were eligible for implantation of the DJBL when they met the following criteria: age 18 to 65 years, body mass index 28 to 45 kg/m(2), T2DM, and negative serum Helicobacter pylori test.
METHODS
Endoscopic implantation of the DJBL.
METHODS
Adverse events, serious adverse events, early explantation.
RESULTS
Between October 2007 and January 2014, 152 of 165 planned implantations (92%) and 94 explantations were performed in our center. Significant weight loss and improvement in T2DM and other cardiovascular parameters were achieved. Early removal of the device occurred because of persistent GI symptoms in 16 patients (11%). Serious adverse events were observed in a subset of patients: 7 GI bleeds, 5 of which required early removal; 2 cases of pancreatitis; 1 case of hepatic abscess; and 1 obstruction of the sleeve. Explantation resulted in an esophageal tear in 2 cases.
CONCLUSIONS
Single-center study.
CONCLUSIONS
The DJBL improves glycemic control while causing weight loss. The safety profile of the DJBL demonstrates a reasonable tolerability profile. However, serious safety adverse events can occur. Patient selection, expert use of the device at placement and removal, and the supportive care of an experienced multidisciplinary team are key for safe and effective use of the DJBL.
