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

ISRCTN ISRCTN91662361
DOI https://doi.org/10.1186/ISRCTN91662361
Secondary identifying numbers HTA 94/41/17
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
27/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Kenneth McColl
Scientific

University Dept of Medicine and Therapeutics
University of Glasgow
44 Church Street
Glasgow
G11 6NT
United Kingdom

Phone +44 (0)141 211 2513
Email K.E.L.McColl@clinmed.gla.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Scientific title
Study objectivesDyspepsia 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(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedDigestive system diseases: Peptic ulcer disease
Intervention1. Endoscopy
2. Non-invasive H. pylori testing
Intervention typeOther
Primary outcome measureGlasgow dyspepsia severity score at one year.
Secondary outcome measuresUse of medical resources, patient oriented outcomes, and safety were also assessed.
Overall study start date01/08/1997
Completion date31/08/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants708
Key inclusion criteriaPatients with dyspepsia who are less than 55 years old with no sinister symptoms
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment01/08/1997
Date of final enrolment31/08/2001

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

University Dept of Medicine and Therapeutics
Glasgow
G11 6NT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 27/04/2002 Yes No