NCT01525732已完成不适用
Prospective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dysphagia score before and after P.O.E.M.
研究概览
简要总结
Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with age ranged 18 to 80 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.
排除标准
- •Patients will be excluded from this study with the followings -
- •Informed consent not available
- •Previous history of esophagectomy or mediastinal surgery
- •Previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection
- •End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow
结局指标
主要结局
Dysphagia score before and after P.O.E.M.
时间窗: From 1st day after POEM to within 2 weeks after POEM
次要结局
- Eckardt score before and after P.O.E.M.(Before and 1 month after POEM)
- Post-operative pain(From Day 1 to until 2 weeks after POEM)
- Operative time(Up to 24 hours)
- Hospital stay(From day of admission till up to 30 days)
- Perioperative complication(30 days after operation)
研究者
Philip Wai Yan Chiu
Professor
Chinese University of Hong Kong
研究点 (1)
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