Prospective Study on the Feasibility and Results of the Treatment of Idiopathic Achalasia With the POEM (Per Oral Endoscopic Myotomy) Technique
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
Treatment options for achalasia include endoscopic dilations and surgical myotomy. Recently the POEM (Per oral endoscopic myotoymy) technique has been described. Patients undergo myotomy under endoscopic control. It has advantage over endoscopic dilation since myotomy is performed, and has advantage over surgery because it is performed endoscopically, thus is less invasive. One potential disadvantage in respect to surgery may be that it may determine higher rates of post-operative reflux. The purpose of this study is to prospectively assess the feasibility of PEOM in our Center with the new hybrid knife, and clinical results at 1, 3 and 12 months.
This is a prospective, phase II study. Ten patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will be included for the POEM procedure.
This study will last about 2 years. The aim is the feasibility, security and success rate of POEM for achalasia. Patients will be followed for at least one year.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years
- •Manometric diagnosis of achalasia
- •Eckardt score more than 3
- •Informed consent
排除标准
- •Increased surgical risk for important comorbidities,
- •Pseudoachalasia
- •Mega-esophagus (more than 7 cm) and or sigmoid esophagus,
- •Previous esophageal or gastric surgery (with the exception of gastric perforation)
- •Inability of completing the questionnarie
- •Inability to keep a commitment for follow-up
- •Esophageal diverticulum
结局指标
主要结局
Feasibility
时间窗: 24 months
Percentage of patients with successful POEM
Clinical Success
时间窗: 24 months
A reduction of 2 or more points in the Eckardt score, that determines a score of 3 or more in 24 months.
次要结局
- Quality of Life(24 months)
- Adverse events(24 months)
- Reflux disease(24 months)
- Efficacy(24 months)
- Treatment failure(24 months)
研究者
Michele Tedeschi
Chief of Clinical research Project
Istituto Clinico Humanitas