Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome

Abstract

Objective: The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS). Summary Background Data: DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study. Methods: We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed. Results: A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) −3.1 kg/m2 (−4.4 to −1.9) kg/m2, P < 0.001] and HbA1c change [mean adjusted difference −0.5% (95% CI −0.9 to −0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%. Conclusions: The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.

Endoscopic Bariatric and Metabolic Therapies and Their Effects on Metabolic Syndrome and Non-alcoholic Fatty Liver Disease - A Systematic Review and Meta-Analysis

“…While Ruban and his colleagues ( 37 ) concluded a significant reduction in weight loss at 12 months, there was no significant difference in %TBWL observed between both groups at 24 months after the removal of DJBL. The other study by Caiazzo et al ( 39 ) also found no significant difference in observed BMI loss after the removal of DJBL.…”

“…Similarly, for the other cardiometabolic risk factors such as blood pressure, EFAs, total cholesterol, and LDL cholesterol, Laubner et al ( 40 ) and Glaysher et al ( 38 ) both showed significant decreases in the DJBL group vs. the SMT group. However, Caiazzo et al ( 39 ) found that there was no significant difference in BMI loss, HOMA2, blood pressure, HDL cholesterol and triglycerides after removal of DJBL. Additionally, with respect to cardiovascular risk profile, Koehestanie et al ( 41 ) found that DJBL intervention could possibly reduce the estimated 10-year coronary heart disease risk by 2 vs. 1% in the control group according to the UK Prospective Diabetes Study Risk Engine ( 42 ).…”

“…The effect of treatment with DJBL on glycemic control remains ambiguous. The Caiazzo study ( 39 ) and Laubner study ( 40 ) both found that HbA1c was significantly decreased in the DJBL group as compared to the SMT group, while the Koehestanie et al ( 41 ) and Ruban et al ( 37 ) studies observed no significant difference between the 2 groups in achieving a reduction in HbA1c at 12 and 24 months respectively. Out of the four studies, three ( 37 , 39 , 40 ) of them with a total of 507 participants assessed the effect of DJBL on %HbA1c change ( Figure 2E ).…”

“…The Caiazzo study ( 39 ) and Laubner study ( 40 ) both found that HbA1c was significantly decreased in the DJBL group as compared to the SMT group, while the Koehestanie et al ( 41 ) and Ruban et al ( 37 ) studies observed no significant difference between the 2 groups in achieving a reduction in HbA1c at 12 and 24 months respectively. Out of the four studies, three ( 37 , 39 , 40 ) of them with a total of 507 participants assessed the effect of DJBL on %HbA1c change ( Figure 2E ). Overall, the DJBL group in these studies experienced a greater reduction in %HbA1c at 12 months as compared to the SMT group, with a WMD of −0.54% (−0.88, −0.20).…”

“…Caiazzo et al ( 39 ) reported 39% of patients who received DJBL experienced at least 1 SAE related to the device. Twenty-two percent required surgical or endoscopic intervention and 16% of the subjects required premature removal of the device, due to occlusion, device migration, abdominal pain, and gastrointestinal hemorrhage.…”