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
- 5
- 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
研究组 & 干预措施
Peroral endoscopic myotomy
Patients with achalasia who are designed to either have balloon dilatation or botulinum toxine injection, or to have surgical intervention (Heller myotomy) for therapy.
Peroral endoscopic myotomy: A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.
干预措施: Endoscopic Peroral Myotomy (Procedure)
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