redoPOEM : Failure of a First POEM

Study Overview
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Brief Summary
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observational study, measurement of efficacy in the cohort.

Detailed Description
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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.

Official Title
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Efficacy and Safety After Failure of a First POEM

Conditions
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Achalasia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Technical failure of redoPOEM Person not affiliated to a Social Security scheme Language barrier preventing fair collection of non-opposition.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy : score of Eckardt | 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. | 3 months after redoPOEM | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety : Number of adverse events of grade II | Evaluation of absence of adverse events of grade II or higher according to AGREE classification. | Through study completion, an average of 1 year | 
| Efficacy : Number of Eckart score strictly below 4 | Evaluation of Eckardt score strictly below 4 at last known follow-up after redoPOEM. Each question is rated from 0 to 3. It consists of 4 items with a total score varies from 0 to 12. | Through study completion, an average of 1 year | 
| Efficacy : Number of new additional procedure | Evaluation of number of an additional procedure because of failure of redoPOEM. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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achalasia, redoPOEM, POEM, per-oral endoscopic myotomy, retrospective, multicenter, efficacy