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Studies

Interventional Recruiting

NCT05899842 on ClinicalTrials.gov

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

Official title: 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

  • Sponsor: Centre Hospitalier Universitaire de NĂ®mes
  • Enrollment: 132 (Estimated)
  • Study start: 2023-06-01 (Actual)
  • Primary completion: 2028-02-01 (Estimated)
  • Study completion: 2028-02-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

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.

Conditions

  • Esophageal Achalasia

Intervention / Treatment

  • Drug: Protein pump inhibitor therapy systematically

Primary Outcome Measures

  • 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

Countries

France

Locations and Investigators

  • AP-HM, Marseille, France (Recruiting)
  • CHU de Montpellier, Montpellier, France (Recruiting)
    • Antoine Debourdeau
    • Antoine Debourdeau (Principal Investigator)
  • Clinique mutualiste Beausoleil, Montpellier, France (Recruiting)
    • Roman Combes
    • Roman Combes (Principal Investigator)
  • CHU de NĂ®mes, NĂ®mes, France (Recruiting)
    • Anissa Megzari
    • Ludovic Caillo (Principal Investigator)

Study Officials

  • Antoine Debourdeau (Principal Investigator) — CHU de Nimes