Prospective Evaluation of PH-impedance Tracings According to the Wingate Consensus, and Influence on GERD Classification According to the Lyon Consensus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaires.
- Who it may be relevant to
- Registry conditions: GERD. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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.
Interventions
- Other Questionnaires
FSSG \& BEDQ
Primary outcome measures
- Statistical difference in the GERD categorisation [Time frame: During baseline visit]
Secondary outcome measures (8)
- 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]
- The analysis of the influence of different parameters on application of the Wingate criteria: including the GERD Symptom Severity; [Time frame: 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; [Time frame: 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); [Time frame: During baseline visit]
- Presence of significant correlations between censored episodes and pH-MII parameters [Time frame: During baseline visit]
- Impact of the Wingate criteria on The number of PSPW; [Time frame: During baseline visit]
- Impact of the Wingate criteria on The number of symptoms associated with an impedance episode. [Time frame: During baseline visit]
- Impact of the Wingate criteria on the number of impedance episodes with or without acidic reflux [Time frame: During baseline visit]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Belgium · 2 centers
- H.U.B — Anderlecht
- UZ Brussel — Jette
Germany · 1 center
- Technische Universität München — München
Identifiers
NCT: NCT06084572 · WinPro