A Prospective Trial Comparing POEM to Pneumatic Dilatation for Treatment of Achalasia Cardia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Clinical success
研究概览
简要总结
The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of achalasia cardia.
详细描述
Achalasia is an esophageal motility disorder which involves smooth muscle of the esophagus and the lower esophageal sphincter (LES). Achalasia causes difficulty swallowing, regurgitation, and sometimes chest pain and weight loss. Endoscopic treatments of achalasia can be provided in the form of dilatation of the LES or cutting of muscle fibers (myotomy) of the esophagus and of the LES under endoscopic viewing. Dilatation in this trial is accomplished with rigiflex balloons and myotomy via Per Oral Endoscopic Myotomy (POEM). The effectiveness of treatment of achalasia using each method will be compared in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Achalasia with Eckardt score at least 3 (0-12 scale achalasia least-most severe)
- •Age 18-75 years
- •Willing and able to comply with the study procedures and provide written informed consent form to participate in the study written informed consent form to participate in the study
排除标准
- •Severe comorbid illness
- •Previous esophageal or gastric surgery
- •Pseudo achalasia
- •Achalasia with esophageal diverticula
- •Pregnancy or lactation
研究组 & 干预措施
Group B - Dilatation
- Pneumatic dilatation using a balloon for treatment of achalasia.
干预措施: Pneumatic Dilatation (Procedure)
Group A - POEM
Per Oral Endoscopic Myotomy for treatment of achalasia
干预措施: Per Oral Endoscopic Myotomy (POEM) (Procedure)
结局指标
主要结局
Clinical success
时间窗: 3 months post procedure
Clinical success defined as reduction of Eckardt score (0-12 scale achalasia least-most severe) of achalasia to an Eckardt score of 3 or less post procedure
次要结局
- Adverse events(1 week post procedure)
研究者
Nageshwar Reddy D
Chairman
Asian Institute of Gastroenterology, India