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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Protein pump inhibitor therapy systematically

Treatment groups

132 Participants
are divided into 2 treatment groups