Achalasia
Conditions
Keywords
achalasia, redoPOEM, POEM, per-oral endoscopic myotomy, retrospective, multicenter, efficacy
Brief summary
observational study, measurement of efficacy in the cohort.
Detailed description
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.
Interventions
None listed
Sponsors
University Hospital, Bordeaux
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy : score of Eckardt | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety : Number of adverse events of grade II | Through study completion, an average of 1 year | Evaluation of absence of adverse events of grade II or higher according to AGREE classification. |
| Efficacy : Number of Eckart score strictly below 4 | Through study completion, an average of 1 year | 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. |
| Efficacy : Number of new additional procedure | Through study completion, an average of 1 year | Evaluation of number of an additional procedure because of failure of redoPOEM. |
Countries
France
Outcome results
None listed