Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial
Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial
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DOI：
10.1053/j.gastro.2006.07.004
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发表时间：
2006-09-01
期刊：
影响因子：
29.4
通讯作者：
Lembo, Anthony
中科院分区：
文献类型：
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作者：
Rothstein, Richard;Filipi, Charles;Lembo, Anthony
背景与目的：本研究的目的是确定内镜下全层应用治疗胃食管反流病（GERD）的有效性，并与假手术进行比较。方法：将需要维持质子泵抑制剂（PPI）治疗的症状性胃食管反流患者纳入随机、单盲、前瞻性、多中心试验。78名患者被随机分配接受内镜下全层贲门重建和经壁缝合。81名患者接受了假手术。在3个月的评估后公布小组分配。主要终点为GERD健康相关生活质量（HRQL）评分改善>= 50%。次要终点包括药物使用和食道酸暴露。结果：意向治疗分析显示，3个月时，活跃组GERD-HRQL评分改善>= 50%的患者比例（56%）显著高于假手术组（18.5%,P < 0.001）。意向治疗分析显示，活性组患者完全停止PPI治疗的比例高于假手术组（50% vs 24%; P = 0.002）。与基线相比，活性组pH < 4的中位数百分比减少率显著提高（7 vs 10.18%, P < 0.001），但假手术组没有（10 vs 9.3%, P = 0.686）。组间分析显示，在改善pH < 4的中位数百分比方面，积极治疗优于假治疗（P = 0.010）。没有穿孔或死亡。结论：内镜下全层应用比假手术更有效地减少胃食管反流症状、PPI使用和食管酸暴露。
Background & Aims: The aim of this study was to determine the effectiveness of endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease (GERD) in comparison with a sham procedure. Methods: Patients with symptomatic GERD requiring maintenance proton pump inhibitor (PPI) therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary end point was >= 50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included medication use and esophageal acid exposure. Results: By intention-to-treat analysis, at 3 months, the proportion of patients achieving >= 50% improvement in GERD-HRQL score was significantly greater in the active group (56%) compared with the sham group (18.5%; P < .001). Complete cessation of PPI therapy was higher among patients in the active group than in the sham group by intention-to-treat analysis (50% vs 24%; P = .002). The percent reduction in median percent time pH < 4 was significantly improved within the active group versus baseline (7 vs 10, 18%, P < .001) but not in the sham group (10 vs 9, -3%, P = .686). Between-group analysis revealed the active therapy to be superior to the sham in improving median percent time pH < 4 (P = .010). There were no perforations or deaths. Conclusions: Endoscopic full-thickness plication more effectively reduces GERD symptoms, PPI use, and esophageal acid exposure than a sham procedure.