Efficacy and Safety After Failure of a First POEM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 14
- 主要终点
- Efficacy : score of Eckardt
研究概览
简要总结
observational study, measurement of efficacy in the cohort.
详细描述
Achalasia is a motor disorder of the esophagus with a prevalence of 1/10000. Multiple treatments have been proposed, including endoscopic dilation, botulinum toxin injection and surgery using the Heller myotomy technique. These techniques are moderately effective and/or carry the risk of per- and post-procedural complications. POEM has been available since 2008, with 80-90% efficacy and 90% safety, and no serious complications have been reported. In the event of failure of a first POEM, a second POEM, known as "redoPOEM", can be proposed. Several studies show efficacy of between 76% and 96% and a safety of between 80% and 86%, with only one serious adverse event reported, and no deaths. However, the studies carried out involved small numbers of patients, generally around 50, the vast majority in Asian countries. The aim of this study was therefore to evaluate the efficacy and safety of redoPOEM reported in patients from several expert centers in Europe.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •adult patient
- •diagnosis of achalasia based on clinical criteria according to Eckardt score, manometry, and radiology when available.
- •failure after POEM (Eckardt score > or equal to 4 in consultation) treated with a new POEM.
- •no active digestive neoplasia.
排除标准
- •Technical failure of redoPOEM
- •Person not affiliated to a Social Security scheme
- •Language barrier preventing fair collection of non-opposition.
结局指标
主要结局
Efficacy : score of Eckardt
时间窗: 3 months after redoPOEM
Evaluation of Eckardt score at 3 months after redoPOEM strictly less than 4. Each question is rated from 0 to 3. It consists of 4 items with a total score varies from 0 to 12.
次要结局
- Safety : Number of adverse events of grade II(Through study completion, an average of 1 year)
- Efficacy : Number of Eckart score strictly below 4(Through study completion, an average of 1 year)
- Efficacy : Number of new additional procedure(Through study completion, an average of 1 year)