Assessment of Gastro-esophageal Reflux Using Endo-Flip vs Bravo
Monitoring oesophageal pH provides a definitive diagnosis of patients with gastro-oesophageal reflux disease (GORD), especially those in whom the association between reflux and symptoms is uncertain and those under consideration for anti-reflux surgery. Standard ambulatory investigation is normally performed by naso-oesophageal catheter however this is associated with considerable discomfort and in turn altered behaviour which reduces reflux provoking activities. Furthermore results of catheter based ambulatory pH studies are compromised by the high variability of acid exposure in patients with suspected GORD.
Prolonging pH measurements by the catheter-free Bravo™ system from 24 to 48 and 96hrs significantly improves the consistency (reliability) and reproducibility of diagnoses based on oesophageal acid exposure, as well as the ability to associate acid reflux to symptom episodes. This improves diagnosis especially in those with intermittent symptoms.
However pH monitoring does not provide a direct assessment of the underlying pathophysiology. Incompetence of the oesophago-gastric junction (OGJ) related to disruption of its structure and function is considered to be the most important cause of GORD. A more relevant assessment of the reflux barrier may be its distensibility (i.e. the ease with which the OGJ is opened to allow retrograde passage of gastric contents); however this is not assessed by current clinical investigations.
Endo-FLIP (Crospon Medical Devices) is a new tool which assesses OGJ structure and function, and appears to provide relevant information regarding its distensibility and competence.
This study applies to using Endo-Flip to record OGJ distensibility and Bravo to record acid exposure and symptom association in patients with reflux symptoms. The variability of pH measurements and symptoms and diagnostic accuracy will be assessed over 96hrs. Endo-FLIP results will then be compared against Bravo. The outcome of post investigation therapy will then be compared with Endo-Flip and Bravo results to assess if baseline testing can predict the outcome of acid suppression therapy.
- There is a positive, continuous association between OGJ distensibility measured by Endo-FLIP on % acid exposure assessed by prolonged Bravo pH monitoring
- The results of Endo-FLIP and prolonged Bravo predict treatment outcome of a trial of proton pump inhibitor therapy
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||What is the Physiologic and Clinical Relevance of Oesophagogastric Junction Distensibility? Studies Using Endo-Flip and 96 Hour Wireless pH System|
- Diagnostic reliability of prolonged wireless pH monitoring and comparison oesophago-gastric junction distensibility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To confirm improved diagnostic reliability and accuracy of prolonged pH measurement by the Bravo™ system in a large, prospective clinical trial
- To confirm that there is a positive, continuous association between oesophago-gastric junction (OGJ) distensibility measured by Endo-FLIP on percentage acid exposure assessed by prolonged Bravo-pH monitoring
- Prediction of treatment outcome with Endo-Flip and Bravo [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To confirm that the results of Endo-FLIP and prolonged Bravo-pH monitoring can predict treatment outcome of a trial of proton pump inhibitor therapy:
- Patients with high OGJ distensibility and high reflux-symptom association with acid regurgitation or cough complain of persistent regurgitation of gastric contents on treatment.
- Patients with low OGJ distensibility and high reflux-association with heartburn complain of persistent heartburn
- Patients with low OGJ distensibility and low reflux-association with any symptom complain of atypical and dyspeptic symptoms
Biospecimen Retention: Samples Without DNA
Biopsies taken at the gastro-oesophageal junction will be sent to histology lab and analysed as per routine histology specimens. These will be stored as all samples at our hospital are stored and only results reported by the appointed histologist will be used for analysis.
|Study Start Date:||September 2010|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481949
|Oesophageal Laboratory, GSTT|
|London, United Kingdom, SE1 7EH|
|Principal Investigator:||Mark Fox, MD||Honorary Consultant and Senior Lecturer|