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NCT04740437 Clinical Trial

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

Gastroesophageal Reflux Clinical Trial

— IPPOEM-Retro  

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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04740437
Other study ID # RECHMPL21_0064
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date March 31, 2022

Study information
Verified date February 2021
Source University Hospital, Montpellier
Contact Antoine Debourdeau, MD
Phone 467330224
Email antoinedebourdeau@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date March 31, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Esophagitis Number of Esophagitis 1 day
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