redoPOEM : Failure of a First POEM

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06044155

Collaborator

(none)

100

Enrollment

Locations

Anticipated Duration (Months)

7.7

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

observational study, measurement of efficacy in the cohort.

Condition or Disease	Intervention/Treatment	Phase
Achalasia

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Efficacy and Safety After Failure of a First POEM

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique des Cèdres	Cornebarrieu	France	31700
2	CHU Dijon Bourgogne	Dijon	France	21079
3	Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer	La Seyne-sur-Mer	France	83500
4	CHU Lille	Lille	France	59037
5	CHU de Limoges	Limoges	France	81042
6	Hospices civils de Lyon	Lyon	France	69003
7	Hôpitaux Universitaires de Marseille Nord	Marseille	France	13915
8	CHU de Nantes	Nantes	France	44093
9	CHU de Nice - Hôpital Archet	Nice	France	06200
10	CHU de Nîmes	Nîmes	France	30029
11	AP-HP Hôpital Cochin	Paris	France	75014
12	CHU de Rennes	Rennes	France	35033
13	CHRU de Nancy	Vandœuvre-lès-Nancy	France	54511