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

Recruiting

• Conditions: GERD
• Interventions: Other: Questionnaires

• Registration Number: NCT06084572
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-09-29
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GERD patients	Questionnaires	-

Primary Outcome Measures

Name	Time	Method
Statistical difference in the GERD categorisation	During baseline visit	the statistical difference in the distribution of GERD categorisation between automated vs. manual review of the pH-MII tracings

Secondary Outcome Measures

Name	Time	Method
The analysis of the influence of different parameters on application of the Wingate criteria: including MNBI (obtained by automated analysis or manually calculated);	During baseline visit
Presence of significant correlations between censored episodes and pH-MII parameters	During baseline visit	Correlations including: * Acid exposure time; * Total number of reflux episodes identified by impedance monitoring; * MNBI; * PSPWI.
The analysis of the influence of different parameters on application of the Wingate criteria: including the GERD Symptom Severity;	During baseline visit
The analysis of the influence of different parameters on application of the Wingate criteria: including the Indication for referral with further classification into predominant oesophageal and extra-oesophageal symptoms;	During baseline visit
Impact of the Wingate criteria on The number of PSPW;	During baseline visit
Impact of the Wingate criteria on The number of symptoms associated with an impedance episode.	During baseline visit
Impact of the Wingate criteria on the number of impedance episodes with or without acidic reflux	During baseline visit
The analysis of the influence of different parameters on application of the Wingate criteria: including the patient being on or off PPI;	During baseline visit

Trial Locations

Locations (3)

H.U.B; 🇧🇪 Anderlecht, Belgium

Technische Universität München; 🇩🇪 München, Germany

UZ Brussel; 🇧🇪 Jette, Belgium