Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter in Patients With Spastic Esophageal Disorders Such as Achalasia
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Effectiveness of intervention (Symptom severity relief according to pre- and post-operative quality of life questionnaire)
研究概览
简要总结
This study evaluates the efficacy and safety of the Per-Oral Endoscopic Myotomy (POEM) technique for lower esophageal sphincter myotomy in patients suffering from spastic esophageal disorders such as achalasia at a Canadian institution.
The investigators hypothesize that POEM is a safe and effective technique for the surgical management of such disorders at our institution.
详细描述
Standard surgical care for spastic esophageal disorders such as achalasia includes a procedure called Heller myotomy.
The treatment in our study, called endoscopic myotomy (also known as peroral endoscopic myotomy - POEM) is different from standard surgery (Heller myotomy) because it is less invasive, is less likely to cause reflux, and usually requires shorter operative times with less loss of blood during the surgery. Although POEM has been adopted worldwide and has proven to be successful, the experience in Canada is very limited to date.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic achalasia or similar spastic esophageal disorder and pre-op barium swallow, manometry, and esophagogastroduodenoscopy being consistent with the diagnosis
- •Ability to undergo general anesthesia
- •Age > 18 yrs and < 85 yrs. of age
- •Ability to give informed consent
- •Candidate for elective Heller myotomy
排除标准
- •Contraindications for esophagogastroduodenoscopy
- •Contraindications for elective Heller myotomy
- •BMI > 45
- •Currently pregnant
- •Refusing to participate in the study or without informed consent
- •Concomitant participation in other clinical trial
结局指标
主要结局
Effectiveness of intervention (Symptom severity relief according to pre- and post-operative quality of life questionnaire)
时间窗: 1 year
次要结局
- pH test (pH level in esophagus)(6 months)
- Surgical complications(30 days)
- LES pressure (according to manometry)(6 months)
- Diameter of the esophageal body(1 year)