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| Sponsored by: |
Guy's and St Thomas' NHS Foundation Trust |
|---|---|
| Information provided by: | Guy's and St Thomas' NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00481949 |
Purpose
The day-to-day variability of oesophageal acid exposure in patients with suspected gastro-oesophageal reflux disease (GORD) is high and 20–30% of patients receive a different diagnosis on repeated 24hr catheter based pH testing, longer periods of recording (e.g. 48hr) may provide more reliable information on which to base clinical decisions; however catheter based techniques are too uncomfortable to allow this in practice.
This study applies a wireless pH monitoring (Bravo™, Medtronic) system to record acid exposure and symptom association with reflux events over 96hr (four days) in patients with reflux symptoms. The variability of pH measurements and symptoms assessed over time will be assessed. The diagnostic accuracy of 24, 48 and 72hr measurements were compared against the overall result from 96hr continuous monitoring.
| Condition |
|---|
|
Gastro-Esophageal Reflux Disease Functional Heartburn |
| Study Type: | Observational |
| Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
| Official Title: | What is the Optimal Duration for Reflux Studies? Studies Using 96 Hour Recordings by a Wireless pH System |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | December 2007 |
Prospective study of 60 consecutive patients referred for the investigations typical reflux symptoms (power calculations to allow comparison of 24hr vs.
48hr pH testing). Endoscopy and trans-oral delivery of the Bravo™ capsule 6cm above the Z-line will be performed. Patients will return after 48 and 96hr to download data. Position will be checked at start, at 48hrs and at 96hrs by pH fall and recoverey on drinking OJ). The day-to-day variability of pH measurements will be calculated. Patients will be classified by acid exposure (abnormal: >4.2% time pH<4) and symptom index (positive SI: >50% association of reflux events and any symptom) during each 24hr and 48hr test period. The reproducibiilty and accuracy of 24hr vs. 48hr pH testing will be assessed with 96hr results as the reference standard.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Angela Anggiansah, PhD | +44 2071884194 | angela.anggiansah@gstt.nhs.uk |
| United Kingdom | |
| Oesophageal Laboratory, GSTT | Recruiting |
| London, United Kingdom, SE1 7EH | |
| Principal Investigator: | Mark Fox, MD | Honorary Consultant and Senior Lecturer |
More Information
| Study ID Numbers: | 05/20702/84 |
| Study First Received: | June 1, 2007 |
| Last Updated: | June 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00481949 History of Changes |
| Health Authority: | United Kingdom: Research Ethics Committee |
|
Gastro-oesophageal reflux disease pH measurement symptom association wireless pH monitoring system |
|
Deglutition Disorders Esophageal Motility Disorders Signs and Symptoms Pyrosis Digestive System Diseases Signs and Symptoms, Digestive |
Esophageal Disorder Gastrointestinal Diseases Heartburn Esophageal Diseases Gastroesophageal Reflux |
|
Deglutition Disorders Esophageal Motility Disorders Signs and Symptoms Digestive System Diseases Signs and Symptoms, Digestive |
Gastrointestinal Diseases Heartburn Esophageal Diseases Gastroesophageal Reflux |
