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
Protocol serial number	HTA 94/41/17
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Digestive system diseases: Peptic ulcer disease
Intervention	1. Endoscopy 2. Non-invasive H. pylori testing
Intervention type	Other
Primary outcome measure(s)	Glasgow dyspepsia severity score at one year.
Key secondary outcome measure(s)	Use of medical resources, patient oriented outcomes, and safety were also assessed.
Completion date	31/08/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	708
Key inclusion criteria	Patients with dyspepsia who are less than 55 years old with no sinister symptoms
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/08/1997
Date of final enrolment	31/08/2001

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

University Dept of Medicine and Therapeutics

Glasgow
G11 6NT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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