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Clinical Trials in France / NCT05899842
Recruiting Not applicable

Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia

NCT05899842 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de Nīmes
Phase
Not applicable
Started
2023-06-01
Last updated
2026-02-10

Condition(s) studied

Esophageal Achalasia

Investigational drug(s) / intervention(s)

Protein pump inhibitor therapy systematically

Protein pump inhibitor therapy systematically: Lansoprazole 30mg once per day

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Presence of pathological acid reflux between groups — Month 6
    According to the Lyon 2018 criteria: Esophagitis grade C or D according to the Los Angeles classification and/or acid exposure \>6% on 24-hour esophageal pH-metry

Trial sites (4)

FacilityCityRegionStatus
AP-HM Marseille France Recruiting
CHU de Montpellier Montpellier France Recruiting
Clinique mutualiste Beausoleil Montpellier France Recruiting
CHU de Nîmes Nîmes France Recruiting

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Other trials for the same condition

MARIMPACH : Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05899842 on ClinicalTrials.gov ↗ ← All trials in France