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.)

中文翻译：

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单独进行氩气血浆凝结术与氩气血浆凝结术加全厚度内镜缝合治疗Roux-en-Y胃旁路术后体重恢复：一项前瞻性随机试验（视频）。

背景和目标

Roux-en-Y胃绕道手术后，大量患者恢复了体重。当与胃空肠造口术（GJ）扩张相关联时，已有报道称采用氩气血浆凝结术（APC）加内镜全厚度缝合（FTS-APC）消融和消融治疗体重增加。但是，仍然缺乏可比较的控制数据。

方法

这是一项试验性单中心开放标签随机试验，比较了单独使用APC与FTS-APC减少经口出口的有效性和安全性。从最低点恢复体重至少20％且GJ≥15 mm的患者被认为是合格的。主要结局是12个月时的总体重减轻百分比（％TWL）。次要结果是不良事件的发生率，代谢实验室参数的改善以及生活质量和饮食行为的改善。

结果

从2017年10月至2018年7月，纳入了40例符合资格标准的患者。两组之间的技术和临床成功率相似。在12个月时，仅APC组的平均％TWL为8.3％±5.5％，而FTS-APC组为7.5％±7.7％（P  = 0.71）。修订前的1小时胃固位保留百分比与12个月TWL≥10％的可能性呈正相关。两组均在12个月时降低了低密度脂蛋白和甘油三酸酯的水平，并在3个月时改善了饮食行为和生活质量。内镜下球囊扩张术成功治疗了2例狭窄症（每组1例）。

结论

就随访一年内的技术和临床结果而言，仅APC就类似于FTS-APC。（临床试验注册号：NCT03094936。）