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NCT Number: NCT06230536

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

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.

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Key information

Conditions

Esophageal Achalasia Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Bordeaux

Pessac, France

Location status: Recruiting

Location contact

Arthur BERGER, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. esophageal clearance

    Time frame: 3 months

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

Secondary outcomes

  1. Efficacy : score of Eckardt

    Time frame: 3 months, 12 months

    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.

  2. Efficacy : esophageal clearance

    Time frame: 3 months

    Evaluation of esophageal clearance at 3 months post-POEM .

  3. Quality of life : Score QLQ-SF36

    Time frame: 3 months

    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).

  4. Quality of life : QLQ-OES24

    Time frame: 3 months

    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.

  5. Quality of life : GERD-HRQL

    Time frame: 3 months

    The 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.

  6. Quality of life : ASQ (Achalasia Quality of Life)

    Time frame: 3 months

    The 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.

  7. Quality of life : RDQ (Reflux Disease Questionnaire):

    Time frame: 3 months

    The 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Arthur BERGER, MD

CONTACT

[email protected]

+33557656439

Florian GROUSEZ

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: MARIMPACH

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 30, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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