Clinical trial NCT05899842: Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia
Official title: Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia. Randomized Open-label Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Achalasia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Per Oral Endoscopic Myotomy (POEM) is a treatment of choice for achalasia with an excellent safety and efficacy profile. There is a high rate of esophagitis related to gastroesophageal reflux following this procedure. There is no recommendation on the prescription of protein pump inhibitors (PPI) after the procedure and no study has studied the benefit of systematic prescription of PPI after POEM for achalasia. The study authors hypothesize that routine PPI prescribing post-POEM for 12 months would reduce the rate of esophageal acid exposure compared to a symptom-based prescribing strategy.


Eligibility criteria: Inclusion Criteria:

* Patient with an indication for esophageal POEM for achalasia
* Patient with all types of achalasia with Eckardt score \> 3
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* Patient with contraindications to PPIs
* Patient with mediastinal and esophageal neoplasia
* Patient with a history of Heller myotomy surgery
* Patients requiring any type of anti-reflux valve surgery
* The subject is in a period of exclusion determined by a previous study
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient is pregnant, parturient or breastfeeding

Primary outcomes:
measure: Presence of pathological acid reflux between groups
timeFrame: Month 6
Secondary outcomes:
measure: Presence of pathological acid reflux between groups
timeFrame: Month 12
measure: Patient quality of life between groups
timeFrame: Week 6
measure: Patient quality of life between groups
timeFrame: Month 6
measure: Patient quality of life between groups
timeFrame: Month 12
measure: Patient health-related quality of life between groups
timeFrame: Week 6
measure: Patient health-related quality of life between groups
timeFrame: Month 6
measure: Patient health-related quality of life between groups
timeFrame: Month 12
measure: Quantity of PPI consumed between groups
timeFrame: Month 3
measure: Quantity of PPI consumed between groups
timeFrame: Month 6
measure: Quantity of PPI consumed between groups
timeFrame: Month 12
measure: Treatment tolerance between groups
timeFrame: Month 12
measure: Achalasia symptoms between groups
timeFrame: Week 6
measure: Achalasia symptoms between groups
timeFrame: Month 6
measure: Achalasia symptoms between groups
timeFrame: Month 12
measure: Pyrosis symptoms between groups
timeFrame: Month 6
measure: Pyrosis symptoms between groups
timeFrame: Month 12
Other outcomes:
Locations:
city: Marseille
country: France
facility: AP-HM
city: Montpellier
country: France
facility: CHU de Montpellier
city: Montpellier
country: France
facility: Clinique mutualiste Beausoleil
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU de Nimes
name: Antoine Debourdeau
role: PRINCIPAL_INVESTIGATOR
References: