Esophageal AchalasiaIPPOEMNCT05899842
Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia
A study testing Protein pump inhibitor therapy systematically in people with Esophageal Achalasia, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
Trial summary
Per Oral Endoscopic Myotomy (POEM) is a treatment of choice for achalasia with an excellent safety and efficacy profile. There is a high rate of esophagitis related to gastroesophageal reflux following this procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Achalasia
- What is being tested?
- Protein pump inhibitor therapy systematically
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Jun 2023to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
AP-HM
Marseille
Jean Michel Gonzalez, 06.22.25.02.50, jean-michel.gonzalez@ap-hm.fr
ean Michel Gonzalez
- Recruiting
CHU de Montpellier
Montpellier
Antoine Debourdeau, 06.68.31.94.89, antoinedebourdeau@hotmail.com
Antoine Debourdeau
- Recruiting
Clinique mutualiste Beausoleil
Montpellier
Roman Combes, 06.76.59.23.48, roman.combes@hotmail.fr
Roman Combes
- Recruiting
CHU de Nîmes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Ludovic Caillo
About this study
Official title: Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia. Randomized Open-label Clinical Trial
Per Oral Endoscopic Myotomy (POEM) is a treatment of choice for achalasia with an excellent safety and efficacy profile. There is a high rate of esophagitis related to gastroesophageal reflux following this procedure. There is no recommendation on the prescription of protein pump inhibitors (PPI) after the procedure and no study has studied the benefit of systematic prescription of PPI after POEM for achalasia. The study authors hypothesize that routine PPI prescribing post-POEM for 12 months would reduce the rate of esophageal acid exposure compared to a symptom-based prescribing strategy.
- Conditions
- Esophageal Achalasia
- Being tested
- Protein pump inhibitor therapy systematically
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein pump inhibitor therapy systematicallyDrug
Lansoprazole 30mg once per day
| Study group | Role | What they receive |
|---|---|---|
| Systematic protein pump inhibitor therapy | Experimental | Not described Receives: Drug: Protein pump inhibitor therapy systematically |
| Protein pump inhibitor therapy as necessary | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pathological acid reflux between groups
According to the Lyon 2018 criteria: Esophagitis grade C or D according to the Los Angeles classification and/or acid exposure >6% on 24-hour esophageal pH-metry
Measured: Month 6
Secondary outcomes (18)
Presence of pathological acid reflux between groups
According to the Lyon 2018 criteria: Esophagitis grade C or D according to the Los Angeles classification and/or acid exposure >6% on 24-hour esophageal pH-metry
Measured: Month 12
Patient quality of life between groups
WHOQOL-BREF questionnaire
Measured: Week 6
Patient quality of life between groups
WHOQOL-BREF questionnaire
Measured: Month 6
Patient quality of life between groups
WHOQOL-BREF questionnaire
Measured: Month 12
Patient health-related quality of life between groups
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Measured: Week 6
Patient health-related quality of life between groups
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Measured: Month 6
Patient health-related quality of life between groups
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Measured: Month 12
Quantity of PPI consumed between groups
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
Measured: Month 3
Quantity of PPI consumed between groups
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
Measured: Month 6
Quantity of PPI consumed between groups
Number of boxes of Lansoprazole consumed as recorded in PPI logbook
Measured: Month 12
Treatment tolerance between groups
Occurrence of adverse events as recorded by the doctor during patient interview using a scale of Grade 1 (minor) to Grade 5 (death)
Measured: Month 12
Achalasia symptoms between groups
Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
Measured: Week 6
Achalasia symptoms between groups
Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
Measured: Month 6
Achalasia symptoms between groups
Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms))
Measured: Month 12
Pyrosis symptoms between groups
Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal
Measured: Month 6
Pyrosis symptoms between groups
Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal
Measured: Month 12
Patient quality of life between groups
WHOQOL-BREF questionnaire
Measured: Inclusion
Patient health-related quality of life between groups
Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jun 2023
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AchalasiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Debourdeau, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899842
- Sponsor's protocol ID
- AOIGCSMERRI/2020/LC-01
- Acronym
- IPPOEM
- Status last verified
- Feb 2026
- First submitted
- 2 Jun 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia. Randomized Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT05899842
- Acronym / sponsor ID
- IPPOEM / AOIGCSMERRI/2020/LC-01
- Conditions
- Esophageal Achalasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Per Oral Endoscopic Myotomy (POEM) is a treatment of choice for achalasia with an excellent safety and efficacy profile. There is a high rate of esophagitis related to gastroesophageal reflux following this procedure. There is no recommendation on the prescription of protein pump inhibitors (PPI) after the procedure and no study has studied the benefit of systematic prescription of PPI after POEM for achalasia. The study authors hypothesize that routine PPI prescribing post-POEM for 12 months would reduce the rate of esophageal acid exposure compared to a symptom-based prescribing strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systematic protein pump inhibitor therapy | Experimental | Drug: Protein pump inhibitor therapy systematically |
| Protein pump inhibitor therapy as necessary | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein pump inhibitor therapy systematicallyLansoprazole 30mg once per day | Drug | Systematic protein pump inhibitor therapy |
Primary outcome
Presence of pathological acid reflux between groups
Time frame: Month 6
According to the Lyon 2018 criteria: Esophagitis grade C or D according to the Los Angeles classification and/or acid exposure >6% on 24-hour esophageal pH-metry
18 secondary outcomes
Presence of pathological acid reflux between groups
Time frame: Month 12
Patient quality of life between groups
Time frame: Week 6
Patient quality of life between groups
Time frame: Month 6
Patient quality of life between groups
Time frame: Month 12
Patient health-related quality of life between groups
Time frame: Week 6
Patient health-related quality of life between groups
Time frame: Month 6
Patient health-related quality of life between groups
Time frame: Month 12
Quantity of PPI consumed between groups
Time frame: Month 3
Quantity of PPI consumed between groups
Time frame: Month 6
Quantity of PPI consumed between groups
Time frame: Month 12
Treatment tolerance between groups
Time frame: Month 12
Achalasia symptoms between groups
Time frame: Week 6
Achalasia symptoms between groups
Time frame: Month 6
Achalasia symptoms between groups
Time frame: Month 12
Pyrosis symptoms between groups
Time frame: Month 6
Pyrosis symptoms between groups
Time frame: Month 12
Patient quality of life between groups
Time frame: Inclusion
Patient health-related quality of life between groups
Time frame: Inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antoine Debourdeau principal investigator
CHU de Nimes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein pump inhibitor therapy systematically in people with Esophageal Achalasia, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine Debourdeau (06.68.31.94.89, a-debourdeau@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of pathological acid reflux between groups (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.