RecruitingOBSERVATIONAL

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

This research focuses on people with achalasia, a condition where the gullet (oesophagus) struggles to move food and drink down to the stomach. Patients often have a treatment called POEM. This study aims to see how well a new test, called HRiM, can check if the gullet is clearing food properly after treatment. HRiM is compared with an older test, the TBE, which uses X-rays. If HRiM proves to be just as good or better, it could mean patients might not need to have as many X-ray tests in the future. The study also tracks symptoms and quality of life over time.

At a glance

Status

Recruiting

Sponsor

University Hospital, Bordeaux

Enrolment target

104

Start

01 Feb 2024

Estimated completion

01 Dec 2028

Esophageal Achalasia

What is this study about?

Imagine your gullet (oesophagus) as a tube that carries food from your mouth to your stomach. If you have a condition called achalasia, this tube doesn't work properly, making it hard for food and drink to pass through, which can cause symptoms like difficulty swallowing. A common treatment for this is called POEM (Per-Oral Endoscopic Myotomy), which helps the gullet relax.

After having POEM, it's important for doctors to check how well your gullet is now moving food. Up until now, a common test for this has been the Timed Barium Esophagogram (TBE). This test involves drinking a liquid that shows up on X-rays, allowing doctors to see how quickly it passes through. However, X-rays expose you to some radiation.

This study is exploring a newer test called High-resolution manometry with impedancemetry (HRiM). This test can also show how well liquids move through your gullet, but it doesn't use X-rays. The main goal of this research is to compare HRiM with the TBE test to see if HRiM is a reliable and accurate way to check how well your gullet is working after POEM. If it is, it could mean fewer X-rays for patients in the future.

Key takeaways

This study compares two ways to check how well the gullet works after achalasia treatment.
It aims to see if a non-X-ray test (HRiM) is as good as or better than an X-ray test (TBE).
Finding an effective non-X-ray test could reduce radiation exposure for patients.
The study looks at long-term symptoms and quality of life after treatment.
It helps doctors understand the best ways to monitor achalasia patients.

Who may be eligible?

To be part of this study, you would need to be an adult (18 years or older) who had the POEM procedure at Bordeaux University Hospital between October 2020 and September 2024.

However, some people won't be able to join. This includes if your first POEM treatment wasn't successful, if you couldn't be contacted for follow-up appointments, or if you didn't complete all the necessary tests (like the Eckardt score, TBE, or HRiM) both before and three months after your POEM procedure.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Did you have POEM treatment at Bordeaux University Hospital?
Was your POEM treatment between October 2020 and September 2024?
Did you complete your routine 3-month follow-up tests (like symptom scores and the gullet function tests) after your POEM?

Answer every question to see your result.

What does participation involve?

This study looked back at information from patients who had already received treatment. If you were one of the patients included, you wouldn't have had any extra appointments or tests beyond what you would normally have as part of your routine care after your POEM procedure. The researchers simply used the results from your usual follow-up checks, such as symptom scores, TBE, and HRiM, which were all done around three months after your POEM treatment. They also looked at your symptom scores one year later to see how you were doing in the longer term.

Potential risks and benefits

This study involved reviewing existing patient information, so there were no additional direct risks or benefits to patients involved, as no new procedures or appointments were required. The potential benefit of the study itself is to doctors and future patients, as it could lead to better ways of checking achalasia treatment which might reduce the need for X-rays. All patients have the right to ask their doctor questions about their medical records being used in research.

Locations (1)

Chu de Bordeaux
Verified postcode
Pessac, France· Recruiting

Common questions

What is achalasia?

Achalasia is a condition where the tube that carries food to your stomach (oesophagus) doesn't work properly, making it hard to swallow.

What is POEM treatment?

POEM is a treatment for achalasia that helps the oesophagus relax so food can pass more easily.

What are the two tests being compared?

The study compares an X-ray test called Timed Barium Esophagogram (TBE) with a non-X-ray test called High-resolution manometry with impedancemetry (HRiM).

Why is this comparison important?

If HRiM works just as well, it could mean patients have fewer X-ray tests in the future, reducing radiation exposure.

Did I have to do anything extra for this study?

No, this study used information from your routine follow-up appointments after POEM treatment, so you wouldn't have had any extra appointments or tests.

How to find out more

Arthur BERGER, MD

arthur.berger@chu-bordeaux.fr +33557656439 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.