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

ConditionGERD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversitair Ziekenhuis Brussel

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged 18 - 80 years old;

pH-MII performed off PPI

Disqualifiers

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;

Trial population

All patients referred for pH-MII are eligible.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaires

    Other intervention

    FSSG \& BEDQ

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: GERD patients1 intervention

Trial outcomes

Primary outcomes

1

Statistical difference in the GERD categorisation

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

Time frame
During baseline visit

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.