Heartburn Clinical Trial
Official title:
What is the Physiologic and Clinical Relevance of Oesophagogastric Junction Distensibility? Studies Using Endo-Flip and 96 Hour Wireless pH System
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.
Study Hypothesis
1. There is a positive, continuous association between OGJ distensibility measured by
Endo-FLIP on % acid exposure assessed by prolonged Bravo pH monitoring
2. The results of Endo-FLIP and prolonged Bravo predict treatment outcome of a trial of
proton pump inhibitor therapy
Status | Completed |
Enrollment | 50 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Provision of written, fully informed consent to undergo mechanistic procedures: Endo-FLIP, endoscopy and biopsy, 4 day wireless pH monitoring by the Bravo system - All subjects should be off acid suppression medication (e.g. PPI, H2RA) for at least 5 days prior to endoscopy Exclusion Criteria: - Significant gastrointestinal symptoms or disease other than reflux - Previous upper GI surgery or interventions such as oesophageal dilatations - Predominant symptoms of motility disorders, e.g. dysphagia - Presence of major oesophageal dysmotility on manometry, e.g. achalasia - Significant co-morbidity requiring ongoing treatment or investigation - Physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures (e.g. physical impairment/reduced mobility) - Pregnant at the time of enrolment - No haematological abnormalities (no anticoagulants) - No medications influencing gastrointestinal function within 3 days of the study. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | Oesophageal Laboratory, GSTT | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic reliability of prolonged wireless pH monitoring and comparison oesophago-gastric junction distensibility | 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 |
1 year | No |
Secondary | Prediction of treatment outcome with Endo-Flip and Bravo | 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 |
2 years | No |
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