Clinical trial NCT06084572: Prospective Evaluation of PH-impedance Tracings According to the Wingate Consensus, and Influence on GERD Classification According to the Lyon Consensus
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GERD
Keywords: GERD
pH-impedance
Wingate-consensus
Lyon consensus
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred for pH-MII are eligible.

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.

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.

Primary outcomes:
measure: Statistical difference in the GERD categorisation
timeFrame: During baseline visit
Secondary outcomes:
measure: 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;
timeFrame: During baseline visit
measure: The analysis of the influence of different parameters on application of the Wingate criteria: including the GERD Symptom Severity;
timeFrame: During baseline visit
measure: The analysis of the influence of different parameters on application of the Wingate criteria: including the patient being on or off PPI;
timeFrame: During baseline visit
measure: The analysis of the influence of different parameters on application of the Wingate criteria: including MNBI (obtained by automated analysis or manually calculated);
timeFrame: During baseline visit
measure: Presence of significant correlations between censored episodes and pH-MII parameters
timeFrame: During baseline visit
measure: Impact of the Wingate criteria on The number of PSPW;
timeFrame: During baseline visit
measure: Impact of the Wingate criteria on The number of symptoms associated with an impedance episode.
timeFrame: During baseline visit
measure: Impact of the Wingate criteria on the number of impedance episodes with or without acidic reflux
timeFrame: During baseline visit
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: H.U.B
city: Jette
country: Belgium
facility: UZ Brussel
city: München
country: Germany
facility: Technische Universität München
Study officials:
References: