GERD
Conditions
Keywords
GERD, pH-impedance, Wingate-consensus, Lyon consensus
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.
Interventions
OTHERQuestionnaires
FSSG & BEDQ
Sponsors
Universitair Ziekenhuis Brussel
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Statistical difference in the GERD categorisation | During baseline visit | the statistical difference in the distribution of GERD categorisation between automated vs. manual review of the pH-MII tracings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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 | — |
| Presence of significant correlations between censored episodes and pH-MII parameters | During baseline visit | Correlations including: * Acid exposure time; * Total number of reflux episodes identified by impedance monitoring; * MNBI; * PSPWI. |
Countries
Belgium, Germany
Contacts
Primary ContactSébastien Kindt, Prof. Dr.
Backup ContactVirgini Van Buggenhout
Outcome results
None listed