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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-29

Study Completion Date

2026-04-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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GERD

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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GERD patients

Questionnaires

Intervention Type OTHER

FSSG \& BEDQ

Interventions

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Questionnaires

FSSG \& BEDQ

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No