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

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.

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

Study Overview

• Status: Recruiting
• Conditions: GERD
• Intervention / Treatment: Other: Questionnaires

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Virgini Van Buggenhout; Phone Number: 60 11 +32 2 477; Email: virgini.vanbuggenhout@uzbrussel.be
• Study Contact Backup: Name: Sébastien Kindt, Prof. Dr.; Phone Number: 60 11 +32 2 477; Email: sebastien.kindt@uzbrussel.be

Study Locations

• Belgium
  • Anderlecht, Belgium, 1080
    • Recruiting
    • H.U.B
    • Contact: Hubert Louis, prof. dr.; Phone Number: +32 (0)2 555 55 55; Email: hubert.louis@hubruxelles.be
  • Jette, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: Sebastien Kindt, MD; Phone Number: 60 11 +32 2 477; Email: sebastien.kindt@uzbrussel.be
• Germany
  • München, Germany, 81675
    • Recruiting
    • Technische Universität München
    • Contact: Alissa Jell, dr.; Phone Number: +49 (0)89 4140-5023; Email: alissa.jell@tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients referred for pH-MII are eligible.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GERD patients	Other: Questionnaires; FSSG & BEDQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statistical difference in the GERD categorisation	the statistical difference in the distribution of GERD categorisation between automated vs. manual review of the pH-MII tracings	During baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 patient being on or off PPI;		During baseline visit
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	Correlations including: Acid exposure time;; Total number of reflux episodes identified by impedance monitoring;; MNBI;; PSPWI.	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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: GERD; pH-impedance; Wingate-consensus; Lyon consensus
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: WinPro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No