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RecruitingNCT06230536

MARIMPACH : Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia

Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia

Status
Recruiting
Phase
Study type
Observational
Enrollment
104 (estimated)
Sponsor
University Hospital, Bordeaux · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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. 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.

Conditions

Timeline

Start date
2024-02-01
Primary completion
2028-03-01
Completion
2028-12-01
First posted
2024-01-30
Last updated
2024-07-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06230536. Inclusion in this directory is not an endorsement.