Personalized Peroral Endoscopic Myotomy for Achalasia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- symptom relief
研究概览
简要总结
Achalasia is a rare esophageal motility disorder, characterized by incomplete lower esophageal sphincter relaxation, increased Lower esophageal sphincter (LES) tone, and aperistalsis of the esophagus. Typical clinical symptoms are dysphagia,regurgitation and chest pain. Traditional treatments include endoscopic balloon dilatation or botulinum toxin injection, laparoscopic Heller myotomy with or without a partial fundoplication. Peroral endoscopic myotomy (POEM) has been developed as a further endoscopic effective and minimal invasive treatment. The aim of this study is to investigate the efficacy and safety of POEM in our department, and to assess short-term and long-term efficacy of POEM by using Stooler score, Echardt score, esophageal barium and manometry.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as achalasia according to symptoms, esophageal barium,manometry and esophagogastroduodenoscopy
- •Age over 18 years old
- •Signed written informed consent
排除标准
- •Patients with previous surgery of the stomach or esophagus
- •With known coagulopathy
- •Active esophagitis,eosinophilic esophagitis or Barrett's esophagus
- •Pregnancy
- •Stricture of the esophagus
- •Hiatal hernia > 2cm
结局指标
主要结局
symptom relief
时间窗: 1-12months
compare patients' symptoms before and after POEM at 1 month, 12 months.
Lower esophageal sphincter pressure
时间窗: 1-12months
compare patients's lower esophageal sphincter pressure before and after POEM at 1 month,12 months.
improvement of esophageal barium
时间窗: 1-12 months
compare esophageal barium before and after POEM at 1 months,12 months
Postoperative complications
时间窗: 0-12months
postoperative complications
次要结局
未报告次要终点
研究者
Zou Xiaoping
vice-principal
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
