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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patients included are all patients treated by POEM at Bordeaux University Hospital between October 2020 and September 2024.

Disqualifiers

Primary POEM failure, lost to follow-up, absence of completion of the ES, TBE or HRiM pre or post poem at 3 months.

Trial 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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

esophageal clearance

Difference of esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM at 3 months

Time frame
3 months

Secondary outcomes

1

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.

Time frame
3 months, 12 months
2

Efficacy : esophageal clearance

Evaluation of esophageal clearance at 3 months post-POEM .

Time frame
3 months
3

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).

Time frame
3 months
4

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.

Time frame
3 months

Other outcomes

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