MARIMPACH : Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Esophageal Achalasia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
Overview
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.
Primary outcome measures
- esophageal clearance [Time frame: 3 months]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Chu de Bordeaux — Pessac
Identifiers
NCT: NCT06230536 · CHUBX 2023/55