Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Improved quality of life as defined by survey pre and post surgery
研究概览
简要总结
This is a study of the safety and efficacy of a new surgical procedure using endoscopic instruments and a tunneling technique to reach the LES for dissection. We hypothesize that this technique provides an incisionless, less invasive option with similar functional outcome compared to standard Heller myotomy.
详细描述
By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer can be easily visualized. In contrast to conventional Heller myotomy, the dissection of only the inner circular esophageal muscle layer leaves the outer longitudinal muscle layer intact. Thereby, post-interventional reflux disease should be avoided.
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
- •Ability to undergo general anesthesia
- •Age > 18 yrs. of age and < 85 yrs. of age
- •Ability to give informed consent
- •Candidate for elective Heller myotomy
排除标准
- •Previous mediastinal or esophageal surgery
- •Contraindications for esophagogastroduodenoscopy
- •BMI > 45
结局指标
主要结局
Improved quality of life as defined by survey pre and post surgery
时间窗: six months
patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.
次要结局
- Negative pH test(six months)
- Bleeding(1 year)
研究者
Lee Swanstrom
Lee Swanstrom, MD
The Oregon Clinic