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

Last updated: June 2, 2023
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Treatment

Protein pump inhibitor therapy systematically

Clinical Study ID

NCT05899842
AOIGCSMERRI/2020/LC-01
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 consentform
  • The patient must be a member or beneficiary of a health insurance plan

Exclusion

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

Study Design

Total Participants: 132
Treatment Group(s): 1
Primary Treatment: Protein pump inhibitor therapy systematically
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • AP-HM

    Marseille,
    France

    Active - Recruiting

  • CHU de Montpellier

    Montpellier,
    France

    Active - Recruiting

  • Clinique mutualiste Beausoleil

    Montpellier,
    France

    Active - Recruiting

  • CHU de Nîmes

    Nîmes,
    France

    Active - Recruiting

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