A significant number of patients regain weight after Roux-en-Y gastric bypass. Ablation with argon plasma coagulation (APC) plus endoscopic full-thickness suturing (FTS-APC) and ablation alone have been reported for treating weight regain when associated with gastrojejunostomy (GJ) dilation. However, comparative controlled data are still lacking.

This was a pilot single-center open-label randomized trial comparing the effectiveness and safety of APC alone versus FTS-APC for transoral outlet reduction. Patients with at least 20% weight regain from the nadir, and GJ ≥15 mm were considered eligible. The primary outcome was percentage total weight loss (%TWL) at 12 months. Secondary outcomes were the incidence of adverse events, amelioration of metabolic laboratory parameters, and improvement in quality of life and eating behavior.

Forty patients meeting the eligibility criteria were enrolled from October 2017 to July 2018. Technical and clinical success rates were similar between the groups. At 12 months, the mean %TWL was 8.3% ± 5.5% in the APC alone group versus 7.5% ± 7.7% in the FTS-APC group (P = .71). The pre-revisional % solid gastric retention at 1 hour positively correlated with the probability of achieving ≥10% TWL at 12 months. Both groups experienced significant reductions in low-density lipoprotein and triglyceride levels at 12 months, and improvement in eating behavior and quality of life at 3 months. There were 2 cases of stenoses (1 from each group), which were successfully treated with endoscopic balloon dilation.

APC alone is similar to FTS-APC in terms of technical and clinical outcomes within 1 year of follow-up. (Clinical trial registration number: NCT03094936.)