A prospective randomised controlled trial of open access endoscopy and near patient testing for Helicobacter pylori antibodies in primary care
| ISRCTN | ISRCTN34856269 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34856269 |
| Secondary identifying numbers | PSI03-07 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 01/04/2009
- 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 FDR Hobbs
Scientific
Scientific
The Department of Primary Care and General Practice
Medical School
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 3765 |
|---|---|
| f.d.r.hobbs@bham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Dyspepsia is common, with an incidence of 2 'new episodes' per 1000 population per year. However, dyspepsia is also a lifelong intermittent and relapsing disorder, with as many as a third of the adult population suffering dyspeptic symptoms in a year. General practitioners have been encouraged to endoscope patients over the age of 50 years, particularly those with recent onset or continuous symptoms, on account of the potential to detect early gastric cancer. However, early gastric cancer is rare and a large number of patients would need to be investigated to detect one case. Malignancy is extremely rare under the age of 50 and current guidelines have concentrated on reducing endoscopy workload by filtering out patients testing negative for Helicobacter pylori, on the basis that they are unlikely to have peptic ulceration, and could be treated with empirical acid suppression, rather than H. pylori eradication therapy. This study was conducted as two identical randomised controlled trials (RCTs), the intervention differing by the age of the patient: 1. For patients of 50 years and over we aimed to determine the cost-effectiveness of initial endoscopy compared to usual management 2. For patients under the age of 50 years we aimed to determine the cost-effectiveness of the H. pylori 'test and endoscope' strategy for managing dyspepsia |
| Ethics approval(s) | Obtained from all local research ethics committees |
| Health condition(s) or problem(s) studied | Peptic ulcer disease |
| Intervention | Under 50 years: Near patient testing for H. pylori (Helisal rapid blood, Cortecs diagnostics, UK) and open-access endoscopy if positive Over 50 years: initial open access endoscopy Controls: prescribing or specialist referral at GP's discretion |
| Intervention type | Other |
| Primary outcome measure | Cost-effectiveness based on symptomatic improvement and health resource utilisation for dyspepsia at 12 months. |
| Secondary outcome measures | 1. Quality of life (QoL) 2. Patient satisfaction |
| Overall study start date | 01/03/1995 |
| Completion date | 01/10/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 430 |
| Key inclusion criteria | 1. Dyspeptic patients 2. Aged 18 years and over (either sex) 3. Helicobacter pylori positive |
| Key exclusion criteria | 1. Previous endoscopy 2. Positive barium meal examination in the past three years 3. Unable to give informed consent 4. Unfit for endoscopy |
| Date of first enrolment | 01/03/1995 |
| Date of final enrolment | 01/10/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Department of Primary Care and General Practice
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 14/04/2001 | Yes | No |
