Argon plasma coagulation alone versus argon plasma coagulation plus full-thickness endoscopic suturing to treat weight regain after Roux-en-Y gastric bypass: a prospective randomized trial (with videos).

BACKGROUND AND AIMS: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSION: 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.).