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

GERD Clinical Trial

— WinPro  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084572
• Other study ID #: WinPro
• Status: Recruiting
• Start date: September 29, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: March 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Sébastien Kindt, Prof. Dr.
• Phone: +32 2 477
• Email: sebastien.kindt[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 catego-rise 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 eval-uate possible confounders to the interpretation, including the indication for referral for pH-MII, symptom severity, use of PPI during pH-MII.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult patients aged 18 - 80 years old;
• pH-MII performed by Medtronic hardware.

Exclusion Criteria:

• Prior upper GI endoscopy indicative of structural disease (except for oesophagitis or hiatal hernia).
• Incomplete pH-MII (less than 21 hours recording);
• Suboptimal quality of the tracings preventing interpretation in clinical practice;
• Prior oesophageal (including anti-reflux intervention) or gastric surgery.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Other:
• Questionnaires
FSSG & BEDQ

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel	Brussels
Belgium	UZ Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Statistical difference in the GRED categorisation	the statistical difference in the distribution of GERD categorisation between automated vs. manual review of the pH-MII tracings	During baseline visit
Secondary	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
Secondary	The analysis of the influence of different parameters on application of the Wingate criteria: including the GERD Symptom Severity;		During baseline visit
Secondary	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
Secondary	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
Secondary	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
Secondary	Impact of the Wingate criteria on The number of PSPW;		During baseline visit
Secondary	Impact of the Wingate criteria on The number of symptoms associated with an impedance episode.		During baseline visit
Secondary	Impact of the Wingate criteria on the number of impedance episodes with or without acidic reflux		During baseline visit