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

Not Applicable

Recruiting

• Conditions: Esophageal Achalasia
• Interventions: Drug: Protein pump inhibitor therapy systematically

• Registration Number: NCT05899842
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-01
• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-02
• Last Update Submitted: 2023-06-02
• Study First Posted: 2023-06-12
• Last Update Posted: 2023-06-12
• Primary Completion: 2026-01
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systematic protein pump inhibitor therapy	Protein pump inhibitor therapy systematically	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Presence of pathological acid reflux between groups	Month 12	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
Patient quality of life between groups	Month 12	WHOQOL-BREF questionnaire
Treatment tolerance between groups	Month 12	Occurrence of adverse events as recorded by the doctor during patient interview using a scale of Grade 1 (minor) to Grade 5 (death)
Patient health-related quality of life between groups	Month 12	Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Quantity of PPI consumed between groups	Month 12	Number of boxes of Lansoprazole consumed as recorded in PPI logbook
Achalasia symptoms between groups	Month 12	Measured as Eckardt score \>3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
Pyrosis symptoms between groups	Month 12	Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal

Trial Locations

Locations (4)

CHU de Nîmes; 🇫🇷 Nîmes, France

Clinique mutualiste Beausoleil; 🇫🇷 Montpellier, France

AP-HM; 🇫🇷 Marseille, France

CHU de Montpellier; 🇫🇷 Montpellier, France