Clinical trial NCT06044155: redoPOEM : Failure of a First POEM
Official title: Efficacy and Safety After Failure of a First POEM
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achalasia
Keywords: achalasia
redoPOEM
POEM
per-oral endoscopic myotomy
retrospective
multicenter
efficacy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with achalasia and failure after POEM treated with a new POEM

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy : score of Eckardt
timeFrame: 3 months after redoPOEM
Secondary outcomes:
measure: Safety : Number of adverse events of grade II
timeFrame: Through study completion, an average of 1 year
measure: Efficacy : Number of Eckart score strictly below 4
timeFrame: Through study completion, an average of 1 year
measure: Efficacy : Number of new additional procedure
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Chu de Bordeaux
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: La Seyne-sur-Mer
country: France
facility: Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer
city: Lille
country: France
facility: CHU Lille
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Hospices civils de Lyon
city: Marseille
country: France
facility: Hôpitaux Universitaires de Marseille Nord
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU de Nice - Hôpital Archet
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: AP-HP Hôpital Cochin
city: Rennes
country: France
facility: CHU de Rennes
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: University Hospital, Bordeaux
name: Arthur BERGER, MD
role: PRINCIPAL_INVESTIGATOR
References: