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Should acid reflux meds be routine after POEM? new trial aims to find out

NCT ID NCT05899842

Disease control Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two strategies for preventing acid reflux after POEM surgery for achalasia: taking a PPI (Lansoprazole) every day for a year versus taking it only when reflux symptoms occur. About 132 participants will be randomly assigned to one of the two groups. The goal is to see which approach better reduces harmful acid exposure in the esophagus.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lansoprazole (a protein pump inhibitor)
What this could lead to
If successful, this could establish a standard approach to prevent acid reflux after POEM surgery, improving patient comfort and reducing complications.
What could go wrong
This is a relatively small, single-center trial. The benefit of routine PPI over symptom-based use may be small, and long-term PPI use carries its own risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

achalasia Esophageal Achalasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal achalasia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HM

    RECRUITING

    Marseille, France

  • CHU de Montpellier

    RECRUITING

    Montpellier, France

  • CHU de Nîmes

    RECRUITING

    Nîmes, France

  • Clinique mutualiste Beausoleil

    RECRUITING

    Montpellier, France

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