redoPOEM : Failure of a First POEM

Achalasia Clinical Trial

— redoPOEM  

Official title:

Efficacy and Safety After Failure of a First POEM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044155
• Other study ID #: CHUBX 2023/17
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

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	Vandœuvre-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