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

Esophageal Achalasia Clinical Trial

— MARIMPACH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06230536
• Other study ID #: CHUBX 2023/55
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: December 2028

Study information

• Verified date: January 2024
• Source: University Hospital, Bordeaux
• Contact: Arthur BERGER, MD
• Phone: +33557656439
• Email: arthur.berger[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2028
• Est. primary completion date: March 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Achalasia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	esophageal clearance	Difference of esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM at 3 months	3 months
Secondary	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.	3 months, 12 months
Secondary	Efficacy : esophageal clearance	Evaluation of esophageal clearance at 3 months post-POEM .	3 months
Secondary	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).	3 months
Secondary	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.	3 months
Secondary	Quality of life : GERD-HRQL	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.	3 months
Secondary	Quality of life : ASQ (Achalasia Quality of Life)	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.	3 months
Secondary	Quality of life : RDQ (Reflux Disease Questionnaire):	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.	3 months