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

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ClinicalTrials.gov Identifier: NCT05899842
Recruitment Status : Recruiting
First Posted : June 12, 2023
Last Update Posted : June 12, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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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.

Condition or disease Intervention/treatment Phase
Esophageal Achalasia Drug: Protein pump inhibitor therapy systematically Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05899842


Contacts
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Contact: Antoine Debourdeau 06.68.31.94.89 a-debourdeau@chu-montpellier.fr

Locations
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France
AP-HM Recruiting
Marseille, France
Contact: Jean Michel Gonzalez    06.22.25.02.50    jean-michel.gonzalez@ap-hm.fr   
Principal Investigator: ean Michel Gonzalez         
CHU de Montpellier Recruiting
Montpellier, France
Contact: Antoine Debourdeau    06.68.31.94.89    antoinedebourdeau@hotmail.com   
Principal Investigator: Antoine Debourdeau         
Clinique mutualiste Beausoleil Recruiting
Montpellier, France
Contact: Roman Combes    06.76.59.23.48    roman.combes@hotmail.fr   
Principal Investigator: Roman Combes         
CHU de Nîmes Recruiting
Nîmes, France
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Ludovic Caillo         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Antoine Debourdeau CHU de Nimes
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT05899842    
Other Study ID Numbers: AOIGCSMERRI/2020/LC-01
First Posted: June 12, 2023    Key Record Dates
Last Update Posted: June 12, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases