A prospective randomised controlled trial of open access endoscopy and near patient testing for Helicobacter pylori antibodies in primary care

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Prof FDR Hobbs

ORCID ID

Contact details

The Department of Primary Care and General Practice
Medical School
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 3765
f.d.r.hobbs@bham.ac.uk

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

PSI03-07

Scientific title

Acronym

Study hypothesis

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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

GP practice

Study type

Treatment

Patient information sheet

Condition

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

Overall study end date

01/10/1999

Reason abandoned (if study stopped)

Participant inclusion criteria

1. Dyspeptic patients
2. Aged 18 years and over (either sex)
3. Helicobacter pylori positive

Participant type(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

430

Participant 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

Recruitment start date

01/03/1995

Recruitment end date

01/10/1999

Countries of recruitment

England, United Kingdom

Study participating centre

The Department of Primary Care and General Practice
Birmingham
B15 2TT
United Kingdom

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funder type

Government

Funder name

NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs