NCT01524471Unknown2 期
Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Dysphagia score
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
- 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 Investigations before and after POEM
结局指标
主要结局
Dysphagia score
次要结局
- Improvement in LES pressure
- Eckhart score
- Operative time
- Length of myotomy
- Time to resume diet
- Morbidities
研究者
研究点 (2)
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