NCT05899842 Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia
| NCT ID | NCT05899842 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Esophageal Achalasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 132 participants in total. It began in 2023-06-01 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Antoine Debourdeau
PRINCIPAL INVESTIGATOR
CHU de Nimes
Frequently Asked Questions
Who can join the NCT05899842 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Achalasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05899842 currently recruiting?
Yes, NCT05899842 is actively recruiting participants. Contact the research team at a-debourdeau@chu-montpellier.fr for enrollment information.
Where is the NCT05899842 trial being conducted?
This trial is being conducted at Marseille, France, Montpellier, France, Montpellier, France, Nîmes, France.
Who is sponsoring the NCT05899842 clinical trial?
NCT05899842 is sponsored by Centre Hospitalier Universitaire de Nīmes. The principal investigator is Antoine Debourdeau at CHU de Nimes. The trial plans to enroll 132 participants.