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NCT Number: NCT05899842

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

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.

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Key information

Conditions

Esophageal Achalasia Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HM, Marseille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein pump inhibitor therapy systematically

Drug

Lansoprazole 30mg once per day

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Patient quality of life between groups

    Time frame: Week 6

    WHOQOL-BREF questionnaire

  3. Patient quality of life between groups

    Time frame: Month 6

    WHOQOL-BREF questionnaire

  4. Patient quality of life between groups

    Time frame: Month 12

    WHOQOL-BREF questionnaire

  5. Patient health-related quality of life between groups

    Time frame: Week 6

    Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)

  6. Patient health-related quality of life between groups

    Time frame: Month 6

    Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)

  7. Patient health-related quality of life between groups

    Time frame: Month 12

    Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)

  8. Quantity of PPI consumed between groups

    Time frame: Month 3

    Number of boxes of Lansoprazole consumed as recorded in PPI logbook

  9. Quantity of PPI consumed between groups

    Time frame: Month 6

    Number of boxes of Lansoprazole consumed as recorded in PPI logbook

  10. Quantity of PPI consumed between groups

    Time frame: Month 12

    Number of boxes of Lansoprazole consumed as recorded in PPI logbook

  11. 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)

  12. Achalasia symptoms between groups

    Time frame: Week 6

    Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))

  13. Achalasia symptoms between groups

    Time frame: Month 6

    Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))

  14. Achalasia symptoms between groups

    Time frame: Month 12

    Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))

  15. Pyrosis symptoms between groups

    Time frame: Month 6

    Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal

  16. Pyrosis symptoms between groups

    Time frame: Month 12

    Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal

  17. Patient quality of life between groups

    Time frame: Inclusion

    WHOQOL-BREF questionnaire

  18. Patient health-related quality of life between groups

    Time frame: Inclusion

    Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine Debourdeau

CONTACT

[email protected]

06.68.31.94.89

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: IPPOEM

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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