Effect of the EndoBarrier Device: a 4-Year Follow-up of a Multicenter Randomized Clinical Trial

Objective To evaluate the long-term effect of the duodenal-jejunal bypass liner (DJBL) on weight loss and glycemic control.

Background Data on the long-term effect of DJBL treatment is still missing.

Methods From 2010 to 2012, 29 patients were treated with the DJBL at center A and center B, as part of a multicenter randomized controlled trial. Prior to implantation and after removal of the DJBL, all patients underwent standardized physical examination and blood sampling. Four years after removal of the DJBL, included patients underwent standardized physical examination and blood sampling as previously performed during the initial study.

Results Out of the 29 patients, 15 patients were eligible for follow-up with a median duration of 42 months. Five patients had successfully received additional bariatric surgery. Four years after explantation of the DJBL, median weight in these 15 patients was 102.0 kg (IQR 94.0-124.6), which was not statistically significantly different from the 106.1 kg at baseline (IQR 99.0-128.4). Median BMI changed from 33.1 kg/m(2) (IQR 32.3-38.5) at baseline to 33.7 kg/m(2) (IQR 31.2-36.9) after follow-up. Patients had a TWL of 2.2% (IQR -1.3-5.6) compared to baseline weight. None of the parameters were significantly different after follow-up compared to baseline.

Conclusions The effect of weight reduction of initial DJBL treatment seems to be diminished after 4 years of follow-up. However, larger prospective studies with long-term follow-up need to be conducted in the future.