Clinical trial NCT06230536: MARIMPACH : Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
Official title: Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Achalasia
Keywords: timed baryum esophagogram
high-resolution manometry with impedancemetry
esophageal clearance
Eckardt score
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Primary outcomes:
measure: esophageal clearance
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy : score of Eckardt
timeFrame: 3 months, 12 months
measure: Efficacy : esophageal clearance
timeFrame: 3 months
measure: Quality of life : Score QLQ-SF36
timeFrame: 3 months
measure: Quality of life : QLQ-OES24
timeFrame: 3 months
measure: Quality of life : GERD-HRQL
timeFrame: 3 months
measure: Quality of life : ASQ (Achalasia Quality of Life)
timeFrame: 3 months
measure: Quality of life : RDQ (Reflux Disease Questionnaire):
timeFrame: 3 months
Other outcomes:
Locations:
city: Pessac
country: France
facility: Chu de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Arthur BERGER, MD
role: PRINCIPAL_INVESTIGATOR
References: