Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06230536
Acronym
MARIMPACH
Enrollment
104
Registered
2024-01-30
Start date
2024-02-01
Completion date
2028-12-01
Last updated
2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Achalasia

Keywords

timed baryum esophagogram, high-resolution manometry with impedancemetry, esophageal clearance, Eckardt score

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.

Interventions

None listed

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
esophageal clearance3 monthsDifference of esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM at 3 months

Secondary

MeasureTime frameDescription
Efficacy : esophageal clearance3 monthsEvaluation of esophageal clearance at 3 months post-POEM .
Quality of life : Score QLQ-SF363 monthsSelf-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).
Quality of life : QLQ-OES243 monthsThe 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.
Efficacy : score of Eckardt3 months, 12 monthsEvaluation 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.
Quality of life : ASQ (Achalasia Quality of Life)3 monthsThe ASQ is a validated 10 questions questionnaire where patients can quantify and qualify symptoms of achalasia such as dysphagia to both solids and liquids, specific types of food, other associated symptoms, and overall health in relation to achalasia.
Quality of life : RDQ (Reflux Disease Questionnaire):3 monthsThe RDQ is a questionnaire in which subjects are asked to report the frequency and severity of their upper gastrointestinal symptoms (six items). There are three subscales that evaluate regurgitation, heartburn, and dyspepsia. The heartburn and regurgitation subscales can be combined into a GERD dimension.
Quality of life : GERD-HRQL3 monthsThe GERD-HRQL was developed to survey symptomatic outcomes and therapeutic effects in patients with GERD. The scale has 11 items, which focus on heartburn symptoms, dysphagia, medication effects and the patient's present health condition.

Countries

France

Contacts

Primary ContactArthur BERGER, MD
arthur.berger@chu-bordeaux.fr+33557656439
Backup ContactFlorian GROUSEZ
florian.grousez@chu-bordeaux.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026