Endoscopic Peroral Myotomy for Treatment of Achalasia: Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 10
- 主要终点
- Eckhard symptom score at 3 month after peroral endoscopic myotomy
研究概览
简要总结
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center setting.
详细描述
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center s
70 patients will be enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the Eckardt symptom score at 3 month after peroral endoscopic myotomy.
Primary outcome:
-Eckhard symptom score 3 month after therapy.
Secondary outcomes:
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
- •Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagogastroduodenoscopy which are consistent with the diagnosis
- •persons of age > 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation
- •Signed written informed consent.
排除标准
- •Patients with previous surgery of the stomach or esophagus
- •Patients with known coagulopathy
- •Previous achalasia-treatment with surgery
- •Patients with liver cirrhosis and/or esophageal varices
- •Active esophagitis
- •Eosinophilic esophagitis
- •Barrett's esophagus
- •Pregnancy
- •Stricture of the esophagus
- •Malignant or premalignant esophageal lesion
- •Candida esophagitis
- •Hiatal hernia > 2cm
结局指标
主要结局
Eckhard symptom score at 3 month after peroral endoscopic myotomy
时间窗: Score is evaluated at 3 month after peroral endoscopic myotomy
Validated symptom score based on dysphagia, pain, regurgitation and weight loss
次要结局
- Lower esophageal sphincter pressure(Lower esophageal sphincter pressure is determined by manometry at 3 month after peroral endoscopic myotomy)
- Reflux Symptoms(Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy)
研究者
Prof. Dr. Thomas Rösch
Prof. Dr. Thomas Roesch, Universitätsklinikum Hamburg-Eppendorf, Endoscopy department
Universitätsklinikum Hamburg-Eppendorf