AchalasiaIPPOEM-RetroNCT04740437
Systematic IPP VS Symptomatic IPP in GERD Prevention After POEM for Achalasia. . A Comparative Retrospective Analysis
An observational study of Achalasia and Gastroesophageal Reflux, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia, Gastroesophageal Reflux
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
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.
Who may be able to join
- > 18 years old
- Consent given
- Achalasia all types with eckhardt score > 3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Antoine Debourdeau, MD, 467330224 ext. 33, antoinedebourdeau@hotmail.com
Mathilde Sanavio-Charrier, MD, 467330224, mathilde.snv@gmail.com
About this study
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.
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.
- Conditions
- Achalasia, Gastroesophageal Reflux
- Keywords
- GERD, POEM, Achalasia, PPI, Esophagitis
- Medical subject headings
- Esophageal Achalasia, Gastroesophageal Reflux, Esophagitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Esophagitis
Number of Esophagitis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Jan 2017
- Primary completion1 Jan 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Debourdeau, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740437
- Sponsor's protocol ID
- RECHMPL21_0064
- Acronym
- IPPOEM-Retro
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: nc
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04740437
- Acronym / sponsor ID
- IPPOEM-Retro / RECHMPL21_0064
- Conditions
- Achalasia, Gastroesophageal Reflux
- Keywords
- GERD, POEM, Achalasia, PPI, Esophagitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 5 Feb 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- > 18 years old
- Consent given
- Achalasia all types with eckhardt score > 3
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Esophagitis
Time frame: 1 day
Number of Esophagitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: Undecided. nc
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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. This study is not recruiting at the moment.
Antoine Debourdeau study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia and Gastroesophageal Reflux, run by University Hospital, Montpellier at 1 site 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoine Debourdeau, MD (467330224 ext. 33, antoinedebourdeau@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Esophagitis (time frame: 1 day). 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 5 Feb 2021.