Esophageal AchalasiaMARIMPACHNCT06230536
MARIMPACH : Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
An observational study of Esophageal Achalasia, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Outcome after treatment of achalasia is usually assessed by the Eckardt score (ES). The timed barium esophagogram (TBE) is used to objectively assess esophageal clearance after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Achalasia
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2024to 1 Dec 2028
- Phase
- Observational
- 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
- Adult, Older adult
Study population: a single cohort of all patients with achalasia and treated by POEM at Bordeaux University Hospital and having performed HRiM and TBE in routine care
Who may be able to join
- The patients included are all patients treated by POEM at Bordeaux University Hospital between October 2020 and September 2024.
Who cannot join
- Primary POEM failure, lost to follow-up, absence of completion of the ES, TBE or HRiM pre or post poem at 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Florian GROUSEZ contact
France1 site, 1 recruiting
- Recruiting
Chu de Bordeaux
Pessac
Arthur BERGER, MD, arthur.berger@chu-bordeaux.fr
About this study
Official title: Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
Outcome after treatment of achalasia is usually assessed by the Eckardt score (ES). The timed barium esophagogram (TBE) is used to objectively assess esophageal clearance after treatment. High-resolution manometry with impedancemetry (HRiM) provides information on esophageal clearance of liquids in addition to motility parameters. The aim of this study was to compare esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM.
Read the 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.
- Conditions
- Esophageal Achalasia
- Keywords
- timed baryum esophagogram, high-resolution manometry with impedancemetry, esophageal clearance, Eckardt score
- Medical subject headings
- Esophageal Achalasia
What is being measured
The primary outcome is the main question the study is designed to answer.
esophageal clearance
Difference of esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM at 3 months
Measured: 3 months
Secondary outcomes (7)
Efficacy : score of Eckardt
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.
Measured: 3 months, 12 months
Efficacy : esophageal clearance
Evaluation of esophageal clearance at 3 months post-POEM .
Measured: 3 months
Quality of life : Score QLQ-SF36
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).
Measured: 3 months
Quality of life : QLQ-OES24
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.
Measured: 3 months
Quality of life : GERD-HRQL
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.
Measured: 3 months
Quality of life : ASQ (Achalasia Quality of Life)
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.
Measured: 3 months
Quality of life : RDQ (Reflux Disease Questionnaire):
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Feb 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Dec 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 University Hospital, BordeauxThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur BERGER, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230536
- Sponsor's protocol ID
- CHUBX 2023/55
- Acronym
- MARIMPACH
- Status last verified
- Jul 2024
- First submitted
- 19 Jan 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
- ClinicalTrials.gov ID
- NCT06230536
- Acronym / sponsor ID
- MARIMPACH / CHUBX 2023/55
- Conditions
- Esophageal Achalasia
- Keywords
- timed baryum esophagogram, high-resolution manometry with impedancemetry, esophageal clearance, Eckardt score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 30 Jan 2024 (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.
Outcome after treatment of achalasia is usually assessed by the Eckardt score (ES). The timed barium esophagogram (TBE) is used to objectively assess esophageal clearance after treatment. High-resolution manometry with impedancemetry (HRiM) provides information on esophageal clearance of liquids in addition to motility parameters. The aim of this study was to compare esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- a single cohort of all patients with achalasia and treated by POEM at Bordeaux University Hospital and having performed HRiM and TBE in routine care
Key inclusion criteria (1 listed)
- The patients included are all patients treated by POEM at Bordeaux University Hospital between October 2020 and September 2024.
Key exclusion criteria (1 listed)
- Primary POEM failure, lost to follow-up, absence of completion of the ES, TBE or HRiM pre or post poem at 3 months.
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
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
7 secondary outcomes
Efficacy : score of Eckardt
Time frame: 3 months, 12 months
Efficacy : esophageal clearance
Time frame: 3 months
Quality of life : Score QLQ-SF36
Time frame: 3 months
Quality of life : QLQ-OES24
Time frame: 3 months
Quality of life : GERD-HRQL
Time frame: 3 months
Quality of life : ASQ (Achalasia Quality of Life)
Time frame: 3 months
Quality of life : RDQ (Reflux Disease Questionnaire):
Time frame: 3 months
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 26 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Florian GROUSEZ contact
Arthur BERGER, MD principal investigator
University Hospital, Bordeaux
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 Esophageal Achalasia, run by University Hospital, Bordeaux 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 1 inclusion and 1 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 26 Jul 2024. 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?
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 Arthur BERGER, MD (+33557656439, arthur.berger@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
esophageal clearance (time frame: 3 months). 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 26 Jul 2024.