Radiofrequency ablation for the treatment of weight regain after Roux-en-Y gastric bypass surgery

Abstract

Roux-en-Y gastric bypass (RYGB) surgery is an established modality for the treatment of morbid obesity. However, approximately one-quarter of patients experience weight regain after initially successful weight loss. Endoscopic therapy targeting the gastric remnant pouch represents a novel potential strategy to re-induce weight loss in this population. We performed a pilot trial of radiofrequency ablation (RFA) of the gastric remnant pouch after RYGB to determine feasibility, safety, and efficacy for weight loss. We identified patients who had undergone RYGB, achieved >40% excess body weight loss (EBWL), and then regained >25% of lost weight. RFA was applied to the gastrojejunal anastomosis and the entire surface area of the gastric remnant pouch. Treatment was repeated at 4 and 8 months if patients did not meet specified weight loss targets. Weekly weights were obtained for 12 months. The primary efficacy outcome was percent EBWL at 12 months, compared with baseline. Twenty-five patients were enrolled at 4 centers. Mean (± standard deviation [SD]) age was 45.4 ± 9.1 years, and 84% (21/25) were female. Mean (± SD) baseline body mass index was 40.2 ± 7.8. Twenty-two of 25 patients completed 12 months of follow-up. At 12 months, median (± SD) EBWL was 18.4% (interquartile ratio 10.8, 33.7; P< .0001). Significant weight loss was seen at 3.5 months (P< .0001) and at 7.5 months (P< .0001), with a significant trend for continued weight loss over the 12-month period (P= .013). Two patients had serious adverse events requiring hospitalization. RFA of the gastric remnant pouch in patients with weight regain after RYGB resulted in significant reductions in excess body weight with an acceptable safety profile. Continued weight loss was observed after each RFA treatment. Further clinical trials in well-selected populations are warranted to determine the optimal number and frequency of RFA treatments and to assess durability of weight loss. (Clinical trial registration number: NCT01910688.).