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IPPOEM-Retro: Systematic IPP VS Symptomatic IPP in GERD Prevention After POEM for Achalasia. . A Comparative Retrospective Analysis

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04740437
Collaborator
(none)
150
Enrollment
1
Location
62.9
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

POEM is a minimally invasive endoscopic therapy that is highly efficacy in the treatment of achalasia of any type. POEM has an increased risk of GERD. Systematic PPI therapy has never been studied for the prevention of post-POEM GERD.

The investigators wish to retrospectively compare patients who have received routine PPI therapy vs. patients who don't.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Interest of Systematic PPI Therapy After POEM vs Symptomatic Use of PPI Therapy in Prevention of Gastroesophageal Reflux Disease After POEM for Esophageal Achalasia. A Comparative Retrospective Analysis.
    Actual Study Start Date :
    Jan 1, 2017
    Anticipated Primary Completion Date :
    Jan 1, 2022
    Anticipated Study Completion Date :
    Mar 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Number of Esophagitis [1 day]

      Number of Esophagitis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • 18 years old

    • Consent given

    • Achalasia all types with eckhardt score > 3

    Exclusion criteria:

    • Patient who is a minor or under judicial protection

    • Pregnant or breastfeeding woman

    • Contraindication to PPIs

    • Carrier of mediastinal and exogastric neoplasia

    • Patient on PPIs prior to the procedure for indication that does not allow for their discontinuation

    • Peptic esophagitis (Grade B, C or D) before or at the time of the procedure

    • Previous treatment with Heller myotomy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: Antoine Debourdeau, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04740437
    Other Study ID Numbers:
    • RECHMPL21_0064
    First Posted:
    Feb 5, 2021
    Last Update Posted:
    Feb 5, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    GERD
    POEM
    Achalasia
    PPI
    Esophagitis
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Esophageal Achalasia

    Study Results

    No Results Posted as of Feb 5, 2021