Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 159
- 试验地点
- 27
- 主要终点
- >/=50% improvement in GERD-Health Related Quality of Life Score
研究概览
简要总结
The aim of this study was to determine the effectiveness of endoscopic full-thickness plication (Plicator; NDO Surgical, Inc., Mansfield, MA) for the treatment of GERD in comparison to a sham procedure.
Patients with symptomatic GERD requiring maintenance proton pump inhibitor 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 endpoint was ≥ 50% improvement in GERD-HRQL score. Secondary endpoints included medication use and esophageal acid exposure.
Patients achieving ≥ 50% improvement in GERD-HRQL score at 3-months versus baseline off-meds were considered responsive to their assigned procedure. Patients who failed to reach this level of improvement at 3-months were considered non-responders. Analysis of these dichotomized variables (responder/non-responder) was done using Fisher's exact test comparing the proportion of responders between the active and sham groups. Intent-to-treat analysis was also performed. The null hypothesis was that the proportion of responders was the same in both the active and sham groups. Testing was done at the 5% level of significance (alpha=0.05).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GERD-HRQL score ≥ 15 while off PPI therapy, and at least 6 points higher than on-PPI score
- •Pathologic esophageal acid exposure, defined as pH<4.0 ≥ 4.5% of a 24- or 48-hour monitoring period or a DeMeester score > 14.7
- •Lower esophageal resting pressure of at least 5mmHg; and
- •Suitability for surgery (American Society of Anesthesiologists Physical Status Classification I or II).
排除标准
- •Significant esophageal dysmotility as determined by manometry
- •Esophagitis grade III or IV (Savary-Miller)
- •Barrett's epithelium
- •Hiatus hernia > 2cm
- •Persistent dysphagia, weight loss, esophageal bleeding, vomiting, gas or bloating
- •Esophageal or gastric varices
- •Previous endoscopic or surgical anti-reflux procedure
- •Other esophageal or gastric surgery
- •Chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis); and
- •Pregnancy.
结局指标
主要结局
>/=50% improvement in GERD-Health Related Quality of Life Score
时间窗: 3-months post-procedure
次要结局
- GERD medication use(3-months post-procedure)
- Esophageal acid exposure(3-months post-procedure)
- Heartburn score as measure by visual analog scale(3-months post-procedure)
- Quality of Life as measure by SF-36(3-months post-procedure)