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

February 4, 2021 updated by: University Hospital, Montpellier

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.

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

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 Contact Backup

Study Locations

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be included from several French university hospitals that have POEM as a treatment for esophageal achalasia and which routinely perform an endoscopic evaluation of esophagitis between 6 to 9 months after the POEM.

Data collection will be retrospective from patient records at each center.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Esophagitis
Time Frame: 1 day
Number of Esophagitis
1 day

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: Antoine Debourdeau, University Hospital, Montpellier

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)

January 1, 2017

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

February 5, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL21_0064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

nc

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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