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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06044155
Other study ID # CHUBX 2023/17
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 3, 2023
Est. completion date January 2024

Study information

Verified date January 2024
Source University Hospital, Bordeaux
Contact Arthur BERGER, MD
Phone +335 57 65 64 39
Email arthur.berger@chu-bordeaux.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

observational study, measurement of efficacy in the cohort.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Chu de Bordeaux Bordeaux
France Clinique des Cèdres Cornebarrieu
France CHU Dijon Bourgogne Dijon
France Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer La Seyne-sur-Mer
France CHU Lille Lille
France CHU de Limoges Limoges
France Hospices civils de Lyon Lyon
France Hôpitaux Universitaires de Marseille Nord Marseille
France CHU de Nantes Nantes
France CHU de Nice - Hôpital Archet Nice
France CHU de Nîmes Nîmes
France AP-HP Hôpital Cochin Paris
France CHU de Rennes Rennes
France CHRU de Nancy VandÅ“uvre-lès-Nancy

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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