Actively Recruiting
Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
Led by University Hospital, Bordeaux · Updated on 2024-07-26
104
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating esophageal clearance in patients with achalasia who have been treated using POEM (Peroral Endoscopic Myotomy). The study aims to compare two methods of assessing esophageal clearance: high-resolution manometry with impedancemetry (HRiM) and timed barium esophagogram (TBE). This comparison may help determine if HRiM can replace TBE, which involves radiation exposure. The study also evaluates treatment outcomes using the Eckardt score, a clinical symptom score, and quality of life assessments. Patients treated with POEM undergo assessments before and after treatment, including the Eckardt score, TBE, and HRiM. Treatment failure is identified by an Eckardt score above 3 at three months after POEM. Incomplete esophageal clearance is defined by specific findings in HRiM or TBE at five minutes. The study observes these measures at three months and follows up with a one-year Eckardt score to understand long-term symptoms. All examinations are part of routine care. Participants will have symptom evaluations, esophageal clearance tests, and quality of life questionnaires at three months and one year after treatment. The study measures esophageal clearance and symptom scores to understand the effectiveness of the assessments. Quality of life is evaluated with several questionnaires. The study is observational and follows patients without altering their routine treatment. Participation lasts at least one year, with data collected during standard medical visits.
CONDITIONS
Brief Title
MARIMPACH : Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients treated by POEM at Bordeaux University Hospital between October 2020 and September 2024
You will not qualify if you...
- Primary POEM failure
- Lost to follow-up
- Absence of completion of the Eckardt score, TBE, or HRiM assessments before or after POEM at 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week before treatment
Participants undergo pre-POEM assessment including esophageal clearance tests using High-resolution Manometry with Impedancemetry (HRiM) and timed barium esophagogram (TBE).
1 to 2 visits depending on assessments
Duration - 3 months post-treatment
Participants treated with POEM are observed with post-POEM assessments of esophageal clearance and symptom scores as part of routine healthcare.
Assessments at 3 months including esophageal clearance and quality of life questionnaires
Duration - Up to 12 months post-treatment
Participants have follow-up evaluations including the Eckardt score to estimate long-term symptoms and quality of life at one year after treatment.
1 visit at 12 months for symptom and quality of life assessment
Trial Site Locations
Total: 1 location
1
Chu de Bordeaux
Pessac, France
Actively Recruiting
Research Team
A
Arthur BERGER, MD
F
Florian GROUSEZ
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here