- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06230536
MARIMPACH : Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia (MARIMPACH)
Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
Study Overview
Status
Conditions
Detailed Description
Consecutive patients treated with POEM had pre and post-POEM assessment with ES, TBE, and HRiM. Treatment failure was defined by an ES > 3 at 3 months post-POEM. Incomplete esophageal clearance (IEC) was defined by the presence of an esophageal stasis > 2 cm at 5 minutes in HRiM and/or TBE. The Eckardt score is evaluated at one year to estimate the prognostic value of measurements of esophageal clearance after treatment on long-term symptoms. The evaluation of the Eckardt score will be compared to the quality of life score. All of these examinations are carried out as part of routine care.
The supposed superiority of HRiM in the evaluation of esophageal clearance, systematically carried out in the assessment of Achalasia, could lead to no longer using TBE which is a irradiating examination for the patient.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Arthur BERGER, MD
- Phone Number: +33557656439
- Email: arthur.berger@chu-bordeaux.fr
Study Contact Backup
- Name: Florian GROUSEZ
- Email: florian.grousez@chu-bordeaux.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The patients included are all patients treated by POEM at Bordeaux University Hospital between October 2020 and September 2024.
Exclusion Criteria:
- Primary POEM failure, lost to follow-up, absence of completion of the ES, TBE or HRiM pre or post poem at 3 months.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
esophageal clearance
Time Frame: 3 months
|
Difference of esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM at 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy : score of Eckardt
Time Frame: 3 months, 12 months
|
Evaluation of Eckardt score at 3 months and 12 months post-POEM .
Each question is rated from 0 to 3. It consists of 4 items with a total score varies from 0 to 12.
|
3 months, 12 months
|
Efficacy : esophageal clearance
Time Frame: 3 months
|
Evaluation of esophageal clearance at 3 months post-POEM .
|
3 months
|
Quality of life : Score QLQ-SF36
Time Frame: 3 months
|
Self-questionnaire in 36 items evaluating the quality of life.
The SF-36 questionnaire is made up of 36 questions which concern the last four weeks, divided into 8 dimensions (Physical activity / Life and relationships with others / Physical pain / Perceived health / Vitality / Limitations due to psychological state / Limitations due to physical state / Mental health).
|
3 months
|
Quality of life : QLQ-OES24
Time Frame: 3 months
|
The QLQ-OES24 consists of 24 items assessing dysphagia, deglutition, abdominal/GI symptoms, eating difficulties, pain, emotional problems relating to esophageal cancer and to side effects of chemotherapy/radiotherapy.
|
3 months
|
Quality of life : GERD-HRQL
Time Frame: 3 months
|
The GERD-HRQL was developed to survey symptomatic outcomes and therapeutic effects in patients with GERD.
The scale has 11 items, which focus on heartburn symptoms, dysphagia, medication effects and the patient's present health condition.
|
3 months
|
Quality of life : ASQ (Achalasia Quality of Life)
Time Frame: 3 months
|
The ASQ is a validated 10 questions questionnaire where patients can quantify and qualify symptoms of achalasia such as dysphagia to both solids and liquids, specific types of food, other associated symptoms, and overall health in relation to achalasia.
|
3 months
|
Quality of life : RDQ (Reflux Disease Questionnaire):
Time Frame: 3 months
|
The RDQ is a questionnaire in which subjects are asked to report the frequency and severity of their upper gastrointestinal symptoms (six items).
There are three subscales that evaluate regurgitation, heartburn, and dyspepsia.
The heartburn and regurgitation subscales can be combined into a GERD dimension.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arthur BERGER, MD, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2023/55
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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