Condition category
Digestive System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

Additional files

Editorial Notes