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

NCT ID: NCT04740437

Last Updated: 2021-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Achalasia Gastroesophageal Reflux

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antoine Debourdeau

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uhmontpellier

Montpellier, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Antoine Debourdeau, MD

Role: CONTACT

467330224 ext. 33

Mathilde Charrier, MD

Role: CONTACT

467330224

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Antoine Debourdeau, MD

Role: primary

467330224 ext. 33

Mathilde Sanavio-Charrier, MD

Role: backup

467330224

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RECHMPL21_0064

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.