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Prospective Evaluation of PH-impedance Tracings According to the Wingate Consensus, and Influence on GERD Classification According to the Lyon Consensus

This study is investigating a common test called pH-MII, which measures acid and non-acid reflux in the gullet. Often, computers help analyse the results, but experts also review them manually. This research aims to understand why some computer-identified reflux episodes are changed or removed during this manual review. We also want to see how these changes affect the diagnosis of reflux disease (GERD). By looking at how different factors, like why someone had the test or if they were taking certain medicines, influence the interpretation, we hope to make the pH-MII test even more accurate and helpful for diagnosing and managing acid reflux.

At a glance

Status
Recruiting
Sponsor
Universitair Ziekenhuis Brussel
Enrolment target
120
Start
29 Sep 2023
Estimated completion
01 Apr 2026

What is this study about?

This research is looking at how we understand and use a special test called pH-MII. This test helps doctors check for acid reflux, which is when stomach acid or other stomach contents flow back up into your food pipe (gullet). It's a common problem that can cause heartburn, indigestion, and other uncomfortable symptoms. The pH-MII test involves wearing a small device for about a day that measures reflux episodes.

When you have a pH-MII test, a computer normally does the first analysis of the results. However, doctors and trained specialists also carefully review these results by hand. This study wants to understand why, sometimes, the manual review changes what the computer initially found. For example, the manual review might decide that some episodes the computer identified as reflux aren't actually reflux. We'll also look at how these changes affect whether someone is diagnosed with reflux disease (GERD) and how severe it's considered.

The main goal is to make sure the pH-MII test is as accurate and helpful as possible. We’ll also consider things like why someone needed the test in the first place, how bad their symptoms are, and if they were taking certain medications (like PPIs, which reduce stomach acid) during the test. This will help us understand if these factors influence how the test results are interpreted and ultimately improve how doctors diagnose and manage GERD for patients like you.

Key takeaways

  • The study examines how pH-MII results are interpreted.
  • It aims to improve accuracy in diagnosing acid reflux (GERD).
  • No extra tests, visits, or medicines are required from participants.
  • Data from previous pH-MII tests will be reviewed.
  • Results could lead to more effective reflux management.

Who may be eligible?

To take part in this study, you need to be an adult between 18 and 80 years old. You also must have had a pH-MII test done without taking certain medications called PPIs (proton pump inhibitors, which reduce stomach acid) during the test period.

There are several reasons why you might not be able to join. For instance, if a previous upper endoscopy (a procedure where a tiny camera looks inside your gullet and stomach) showed a structural problem like a severe blockage or other serious issues (though mild gullet inflammation or a common condition called a hiatal hernia are usually okay). You also can't participate if your pH-MII recording was too short (less than 21 hours), or if the recording quality wasn't good enough for doctors to properly interpret. Finally, if you've had surgery on your gullet or stomach, especially surgery for reflux, you wouldn't be able to join this study.

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.

  1. Are you between 18 and 80 years old?
  2. Did you have your pH-MII test without taking acid-reducing medicines (PPIs) at the time?
  3. Have you NOT had major stomach or gullet surgery (especially for reflux)?
  4. Did you NOT have an endoscopy showing severe structural problems?
  5. Was your pH-MII recording at least 21 hours long and of good quality?
Answer every question to see your result.

What does participation involve?

This study is mainly about reviewing existing information. If you're eligible, it means you've already had a pH-MII test at UZ Brussel. Your involvement would not require any extra visits, tests, or changes to any medication you are taking. The researchers will be looking at the results of your pH-MII test and other information from your medical records. You won't need to do anything additional, and there's no ongoing follow-up for this specific research.

Potential risks and benefits

Since this study involves looking back at information from tests you've already had, there are no additional physical risks or discomforts for you. The main potential benefit is that the findings could help doctors better understand and use the pH-MII test, which might lead to more accurate diagnoses and better treatment for people with reflux in the future. You always have the right to withdraw your consent for your data to be used in the study at any time, without it affecting your medical care.

Locations (3)

  • H.U.B
    Verified postcode
    Anderlecht, Belgium· Recruiting
  • UZ Brussel
    Verified postcode
    Jette, Belgium· Recruiting
  • Technische Universität München
    Verified postcode
    München, Germany· Recruiting

Common questions

What is GERD?

GERD stands for Gastro-Oesophageal Reflux Disease. It's a common condition where stomach acid or contents flow back up into your food pipe, causing symptoms like heartburn.

What is a pH-MII test?

It's a test that measures how much acid and non-acid liquid flows back into your food pipe over about a day, to help diagnose reflux.

Will I have to take new medicine?

No, this study is reviewing past information and does not involve taking any new medications.

Do I need to visit the hospital again?

No, you do not need any extra hospital visits for this specific study.

How will this study help people?

By understanding the pH-MII test better, doctors can make more accurate diagnoses of reflux, which can lead to better treatment plans for patients.

How to find out more

Sébastien Kindt, Prof. Dr.

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

Interested in taking part?

Register your interest

Share your details and the research team for "Prospective Evaluation of PH-impedance Tracings According to…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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