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

Last updated: March 13, 2025
Sponsor: Universitair Ziekenhuis Brussel
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Esophageal Disorders

Treatment

Questionnaires

Clinical Study ID

NCT06084572
WinPro
  • Ages 18-80
  • All Genders

Study Summary

Commonly, in clinical practice an automated analysis of pH-MII tracings is obtained.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients aged 18 - 80 years old;

  • pH-MII performed off PPI

Exclusion

Exclusion Criteria:

  • Prior upper GI endoscopy indicative of structural disease (except for oesophagitisor 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.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Questionnaires
Phase:
Study Start date:
September 29, 2023
Estimated Completion Date:
April 01, 2026

Study Description

All pH-MII performed in UZ Brussel are already reviewed manually according to the Wingate con-sensus and interpreted according to the Lyon consensus. In this study, we will prospectively categorise the reasons for discarding reflux episodes identified by automated analysis during the manual review according to the Wingate consensus, as well as the impact on different parameters related to the interpretation of pH-MII. Based on comments received to our retrospective study, we will evaluate possible confounders to the interpretation, including the indication for referral for pH-MII, symptom severity, use of PPI during pH-MII.

Connect with a study center

  • UZ Brussel

    Brussel, Brussels 1090
    Belgium

    Site Not Available

  • H.U.B

    Anderlecht, 1080
    Belgium

    Active - Recruiting

  • UZ Brussel

    Jette, 1090
    Belgium

    Active - Recruiting

  • Technische Universität München

    München, 81675
    Germany

    Active - Recruiting

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