Actively Recruiting
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
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2026-02-10
132
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of protein pump inhibitors (PPIs) to prevent gastroesophageal reflux after Per Oral Endoscopic Myotomy (POEM), a treatment for esophageal achalasia. This condition affects the esophagus and POEM is known for its safety and effectiveness, but many patients experience acid reflux afterward. The study aims to compare routine PPI use for 12 months versus prescribing PPIs only when symptoms appear to see which approach better reduces acid reflux. Participants will be randomly assigned to one of two groups: one receiving lansoprazole 30mg once daily as a systematic PPI therapy for 12 months, and the other receiving PPI therapy only as needed based on symptoms. This is an open-label trial, meaning both participants and researchers know the treatment group. The study will monitor participants over a year to observe differences in acid reflux and other health outcomes. Throughout the study, participants will have assessments at various time points to measure the presence of acid reflux, quality of life, symptom severity, and treatment tolerance. The primary outcome is the presence of pathological acid reflux at 6 months, with secondary outcomes including quality of life and symptom measures at weeks 6, 6 months, and 12 months. The trial will also track the amount of PPI used and evaluate safety and tolerability over the year-long follow-up.
CONDITIONS
Brief 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
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive protein pump inhibitor therapy either systematically or as needed after undergoing per oral endoscopic myotomy for esophageal achalasia.
Visits occur for assessments at Week 6, Month 3, Month 6, and Month 12
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
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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