Actively Recruiting
Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2026-02-10
132
Participants Needed
4
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with an indication for esophageal POEM for achalasia
- Patient with all types of achalasia with Eckardt score > 3
- Patient has given free and informed consent and signed the consent form
- Patient must be a member or beneficiary of a health insurance plan
You will not qualify if you...
- Patient with contraindications to proton pump inhibitors (PPIs)
- Patient with mediastinal and esophageal neoplasia
- Patient with a history of Heller myotomy surgery
- Patients requiring any type of anti-reflux valve surgery
- Subject is in a period of exclusion determined by a previous study
- Impossible to give the subject informed information
- Patient is under safeguard of justice or state guardianship
- Patient is pregnant, parturient, or breastfeeding
AI-Screening
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Trial Site Locations
Total: 4 locations
1
AP-HM
Marseille, France
Actively Recruiting
2
CHU de Montpellier
Montpellier, France
Actively Recruiting
3
Clinique mutualiste Beausoleil
Montpellier, France
Actively Recruiting
4
CHU de Nîmes
Nîmes, France
Actively Recruiting
Research Team
A
Antoine Debourdeau
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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