| Source of record | UK Trials |
| ISRCTN | ISRCTN91662361 |
| Date ISRCTN assigned | 25/04/2003 |
| Local reference number(s) | HTA 94/41/17 |
| Public title | 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Digestive system diseases: Peptic ulcer disease |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients with dyspepsia who are less than 55 years old with no sinister symptoms |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material |
|
| Anticipated start date | 01/08/1997 |
| Anticipated end date | 31/08/2001 |
| Status of trial | Completed |
| Target number of participants | 708 |
| Interventions | 1. Endoscopy
2. Non-invasive H. pylori testing |
| Primary outcome measure(s) | Glasgow dyspepsia severity score at one year. |
| Secondary outcome measure(s) | Use of medical resources, patient oriented outcomes, and safety were also assessed. |
| Publications | http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11976239 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Department of Health (UK) |
| Sponsor details | Quarry House
Quarry Hill
Leeds
United Kingdom
LS2 7UE |
| Sponsor email | Sheila.Greener@doh.gsi.gov.uk |
| Sponsor website | http://www.dh.gov.uk/en/index.htm |
| Contact name | Prof Kenneth McColl |
| Contact details | University Dept of Medicine and Therapeutics
University of Glasgow
44 Church Street
Glasgow
United Kingdom
G11 6NT |
| Contact telephone | +44 (0)141 211 2513 |
| Contact fax | +44 (0)141 339 2800 |
| Contact email | K.E.L.McColl@clinmed.gla.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN91662361 |
| Date last extracted from ISRCTN register | 17/04/2008 |
