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

February 6, 2026 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France
        • Recruiting
        • AP-HM
        • Contact:
        • Principal Investigator:
          • ean Michel Gonzalez
      • Montpellier, France
        • Recruiting
        • CHU de Montpellier
        • Contact:
        • Principal Investigator:
          • Antoine Debourdeau
      • Montpellier, France
        • Recruiting
        • Clinique mutualiste Beausoleil
        • Contact:
        • Principal Investigator:
          • Roman Combes
      • Nîmes, France
        • Recruiting
        • CHU de Nîmes
        • Contact:
        • Principal Investigator:
          • Ludovic CAILLO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Systematic protein pump inhibitor therapy
Drug: Protein pump inhibitor therapy systematically
Lansoprazole 30mg once per day
No Intervention: Protein pump inhibitor therapy as necessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of pathological acid reflux between groups
Time Frame: 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
Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of pathological acid reflux between groups
Time Frame: 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
Month 12
Patient quality of life between groups
Time Frame: Week 6
WHOQOL-BREF questionnaire
Week 6
Patient quality of life between groups
Time Frame: Month 6
WHOQOL-BREF questionnaire
Month 6
Patient quality of life between groups
Time Frame: Month 12
WHOQOL-BREF questionnaire
Month 12
Patient health-related quality of life between groups
Time Frame: Week 6
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Week 6
Patient health-related quality of life between groups
Time Frame: Month 6
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Month 6
Patient health-related quality of life between groups
Time Frame: Month 12
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Month 12
Quantity of PPI consumed between groups
Time Frame: Month 3
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
Month 3
Quantity of PPI consumed between groups
Time Frame: Month 6
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
Month 6
Quantity of PPI consumed between groups
Time Frame: Month 12
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
Month 12
Treatment tolerance between groups
Time Frame: 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)
Month 12
Achalasia symptoms between groups
Time Frame: Week 6
Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
Week 6
Achalasia symptoms between groups
Time Frame: Month 6
Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
Month 6
Achalasia symptoms between groups
Time Frame: Month 12
Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
Month 12
Pyrosis symptoms between groups
Time Frame: Month 6
Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal
Month 6
Pyrosis symptoms between groups
Time Frame: Month 12
Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal
Month 12
Patient quality of life between groups
Time Frame: Inclusion
WHOQOL-BREF questionnaire
Inclusion
Patient health-related quality of life between groups
Time Frame: Inclusion
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Antoine Debourdeau, CHU de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOIGCSMERRI/2020/LC-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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