Contact information
Type
Scientific
Primary contact
Prof Kenneth McColl
ORCID ID
Contact details
University Dept of Medicine and Therapeutics
University of Glasgow
44 Church Street
Glasgow
G11 6NT
United Kingdom
+44 (0)141 211 2513
K.E.L.McColl@clinmed.gla.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 94/41/17
Study information
Scientific title
Acronym
Study hypothesis
Dyspepsia is a common problem in the U.K. and accounts for 10% of GP attendance and 30% of hospital GI clinic referrals. Patients with persisting dyspepsia are investigated by upper GI endoscopy in order to diagnose the underlying cause and determine the most appropriate management. The demand for diagnostic endoscopy continues to increase and currently costs the NHS more than 100 million per year. The procedure also causes the patient significant discomfort and inconvenience.
Studies in our own unit and other centres suggests that non-invasive Helicobacter pylori testing might replace endoscopy in determining the management of a substantial proportion of patients with simple dyspepsia. In order to asses this we propose a randomised controlled trial comparing endoscopy versus non-invasive H.pylori testing in patients with dyspepsia who are less than 55 years and have no sinister symptoms. The study will also allow identification of the patients who will benefit most from the non-endoscopic management. The ability to replace endoscopy by non-invasive test should result in major savings to the health budget and save the patient the discomfort of invasive procedure. It will also allow most dyspeptic patients to be managed definitively in primary care and without the need to attend hospital clinics or endoscopy units.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Digestive system diseases: Peptic ulcer disease
Intervention
1. Endoscopy
2. Non-invasive H. pylori testing
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Glasgow dyspepsia severity score at one year.
Secondary outcome measures
Use of medical resources, patient oriented outcomes, and safety were also assessed.
Overall trial start date
01/08/1997
Overall trial end date
31/08/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with dyspepsia who are less than 55 years old with no sinister symptoms
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
708
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/08/1997
Recruitment end date
31/08/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Dept of Medicine and Therapeutics
Glasgow
G11 6NT
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11976239
Publication citations
-
Results
McColl KE, Murray LS, Gillen D, Walker A, Wirz A, Fletcher J, Mowat C, Henry E, Kelman A, Dickson A, Randomised trial of endoscopy with testing for Helicobacter pylori compared with non-invasive H pylori testing alone in the management of dyspepsia., BMJ, 2002, 324, 7344, 999-1002.