Comparing routine and symptom-based PPI therapy after a procedure for esophageal achalasia
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
This study is testing whether giving patients with esophageal achalasia a routine 12-month prescription for heartburn medication after a specific procedure can help prevent throat inflammation better than only giving the medication when they have symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 4 sites (Marseille and 3 other locations) |
| Trial ID | NCT05899842 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of routine prescription of protein pump inhibitors (PPIs) for 12 months following Per Oral Endoscopic Myotomy (POEM) in patients with esophageal achalasia. The researchers aim to determine if this approach can reduce the incidence of esophagitis related to gastroesophageal reflux compared to a strategy that prescribes PPIs only when symptoms arise. Patients eligible for the study must have a high Eckardt score indicating significant achalasia symptoms and must provide informed consent. The study is conducted at multiple locations in France, including Nīmes, Marseille, and Montpellier.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with esophageal achalasia who are scheduled for POEM and have an Eckardt score greater than 3.
Not a fit: Patients with contraindications to PPIs or those who have undergone previous anti-reflux surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of gastroesophageal reflux in patients undergoing POEM for achalasia.
How similar studies have performed: While there is limited research on systematic PPI use post-POEM, the approach is novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Marseille and 3 other locations
- Ap-Hm — Marseille, France (Recruiting)
- CHU de Montpellier — Montpellier, France (Recruiting)
- Clinique mutualiste Beausoleil — Montpellier, France (Recruiting)
- CHU de Nîmes — Nîmes, France (Recruiting)
Study contacts
- Principal investigator: Antoine Debourdeau — CHU de Nimes
- Study coordinator: Antoine Debourdeau
- Email: a-debourdeau@chu-montpellier.fr
- Phone: 06.68.31.94.89
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.