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

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

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 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.

Official Title
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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.

Conditions
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GERD

Intervention / Treatment
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* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GERD patients<br> | Other: Questionnaires<br>* FSSG & BEDQ<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The analysis of the influence of different parameters on application of the Wingate criteria: including the GERD Symptom Severity; |  | 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; |  | 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); |  | During baseline visit | 
| 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 | 
| Impact of the Wingate criteria on The number of PSPW; |  | During baseline visit | 
| Impact of the Wingate criteria on The number of symptoms associated with an impedance episode. |  | During baseline visit | 
| Impact of the Wingate criteria on the number of impedance episodes with or without acidic reflux |  | During baseline visit |