NCT05259579Unknown不适用
Anti-reflux Mucosal Ablation (ARMA) for the Treatment of Postoperative Gastroesophageal Reflux After Sleeve Gastrectomy - A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in GERD symptoms
研究概览
简要总结
This study is a pilot trial designed to evaluate the safety and efficacy of endoscopic anti-reflux ablation in postoperative gastroesophageal reflux after sleeve gastrectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with reflux symptoms after sleeve gastrectomy and are dependent on or refractory to PPI treatment
- •Pathological esophageal acid exposure, defined by DeMeester score >14.7 or acid exposure time (AET) >4.2% on pH study
排除标准
- •Primary esophageal motility disorders
- •Sliding hiatal hernia >3cm
- •Narrow gastric sleeve that precludes retroflexion of scope
- •Gastric sleeve stricture
- •Malignancy
- •Pregnancy
- •Patients not fit for general anesthesia
- •Other cases deemed by the examining physician as unsuitable for safe treatment
- •Refusal to participate
结局指标
主要结局
Change in GERD symptoms
时间窗: 3 and 6months
Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire score \[0-75, higher scores mean worse outcome\]
次要结局
- Technical success rate(1 day)
- Changes in cardia morphology(3 months)
- Dysphagia symptoms(3 and 6 months)
- Adverse events rate relating to endoscopic intervention(7 days, 1, 3 and 6 months)
- Change in DeMeester score and AET(3 months)
- PPI use(3 and 6 months)
研究者
Stephen K.K. Ng
Principal Investigator
Chinese University of Hong Kong
研究点 (1)
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