Evaluating pH-impedance tracings for GERD classification
Prospective Evaluation of PH-impedance Tracings According to the Wingate Consensus, and Influence on Gastro-oesophageal Reflux Disease (GERD) Classification According to the Lyon Consensus.
Universitair Ziekenhuis Brussel · NCT06084572
This study is testing how pH-impedance tracings can help better classify gastroesophageal reflux disease (GERD) in patients by looking at why some reflux episodes are ignored and considering factors like symptom severity and medication use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel (other) |
| Locations | 3 sites (Anderlecht and 2 other locations) |
| Trial ID | NCT06084572 on ClinicalTrials.gov |
What this trial studies
This observational study aims to prospectively evaluate pH-impedance tracings in patients with gastroesophageal reflux disease (GERD) by categorizing reasons for discarding reflux episodes identified through automated analysis. The study will manually review these tracings according to the Wingate consensus and assess their impact on GERD classification based on the Lyon consensus. Additionally, it will explore potential confounders such as symptom severity and the use of proton pump inhibitors (PPIs) during the pH-MII procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have undergone pH-MII testing without the influence of PPIs.
Not a fit: Patients with prior upper GI endoscopy indicating structural disease or those who have undergone gastric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of GERD classification and improve patient management strategies.
How similar studies have performed: Previous studies have shown promise in improving GERD diagnosis through similar methodologies, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged 18 - 80 years old; * pH-MII performed off PPI Exclusion Criteria: * Prior upper GI endoscopy indicative of structural disease (except for oesophagitis or hiatal hernia). * Incomplete pH-MII (less than 21 hours recording); * Ph-MII performed on PPI * Suboptimal quality of the tracings preventing interpretation in clinical practice; * Prior oesophageal (including anti-reflux intervention) or gastric surgery.
Where this trial is running
Anderlecht and 2 other locations
- H.U.B — Anderlecht, Belgium (RECRUITING)
- UZ Brussel — Jette, Belgium (RECRUITING)
- Technische Universität München — München, Germany (RECRUITING)
Study contacts
- Study coordinator: Sébastien Kindt, Prof. Dr.
- Email: sebastien.kindt@uzbrussel.be
- Phone: +32 2 477
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: GERD, pH-impedance, Wingate-consensus, Lyon consensus