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NCT Number: NCT06084572

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

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

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

H.U.B, Anderlecht, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

questionnaires

Other

FSSG & BEDQ

Primary outcomes

  1. Statistical difference in the GERD categorisation

    Time frame: During baseline visit

    the statistical difference in the distribution of GERD categorisation between automated vs. manual review of the pH-MII tracings

Secondary outcomes

  1. 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;

    Time frame: During baseline visit

  2. The analysis of the influence of different parameters on application of the Wingate criteria: including the GERD Symptom Severity;

    Time frame: During baseline visit

  3. The analysis of the influence of different parameters on application of the Wingate criteria: including the patient being on or off PPI;

    Time frame: During baseline visit

  4. The analysis of the influence of different parameters on application of the Wingate criteria: including MNBI (obtained by automated analysis or manually calculated);

    Time frame: During baseline visit

  5. Presence of significant correlations between censored episodes and pH-MII parameters

    Time frame: During baseline visit

    Correlations including:

    • Acid exposure time;
    • Total number of reflux episodes identified by impedance monitoring;
    • MNBI;
    • PSPWI.

  6. Impact of the Wingate criteria on The number of PSPW;

    Time frame: During baseline visit

  7. Impact of the Wingate criteria on The number of symptoms associated with an impedance episode.

    Time frame: During baseline visit

  8. Impact of the Wingate criteria on the number of impedance episodes with or without acidic reflux

    Time frame: During baseline visit

Study contacts

Contact information is provided by the study sponsor or research team.

Sébastien Kindt, Prof. Dr.

CONTACT

[email protected]

+32 2 477 ext. 60 11

Virgini Van Buggenhout

CONTACT

[email protected]

+32 2 477 ext. 60 11

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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.

Acronym: WinPro

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2023
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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