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ISRCTN
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ISRCTN91662361
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ClinicalTrials.gov identifier
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Public title
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Randomised trial comparing the efficacy and costs of endoscopy with Helicobacter pylori testing versus non-invasive Helicobacter pylori testing alone in the management of dyspepsia
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 94/41/17
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Digestive system diseases: Peptic ulcer disease
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Participants - inclusion criteria
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Patients with dyspepsia who are less than 55 years old with no sinister symptoms
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/08/1997
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Anticipated end date
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31/08/2001
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Status of trial
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Completed
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Patient information material
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Target number of participants
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708
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Interventions
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1. Endoscopy
2. Non-invasive H. pylori testing
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Primary outcome measure(s)
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Glasgow dyspepsia severity score at one year.
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Secondary outcome measure(s)
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Use of medical resources, patient oriented outcomes, and safety were also assessed.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11976239
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Contact name
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Prof
Kenneth
McColl
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Address
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University Dept of Medicine and Therapeutics
University of Glasgow
44 Church Street
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City/town
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Glasgow
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Zip/Postcode
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G11 6NT
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Country
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United Kingdom
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Tel
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+44 (0)141 211 2513
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Fax
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+44 (0)141 339 2800
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Email
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K.E.L.McColl@clinmed.gla.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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25/01/2008
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Date ISRCTN assigned
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25/04/2003
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