BEST3
Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial
N = 13,514
- Population
- Patients aged 50 years or older taking acid-suppressing medication for reflux symptoms for more than 6 months, with no endoscopy in the previous 5 years
- Design
- Pragmatic randomised trial in 109 general practice clinics in England, with randomisation at clinic level (cluster) and at patient level, analysed separately then combined. Intervention: usual care plus an offer of the Cytosponge-TFF3 test, with endoscopy if TFF3-positive cells were found; control: usual care (endoscopy only if the general practitioner requested it). Primary outcome: Barrett's oesophagus diagnosed within 12 months, as a rate per 1000 person-years, in all participants offered the test whether or not they accepted. Enrolment March 2017 to March 2019. ISRCTN68382401 (not an NCT number).
- Primary endpoint
- Barrett oesophagus diagnoses per 1000 person-years
- Arms
- Offer of Cytosponge-TFF3 test (experimental, n = 6,983): Usual care plus an offer of the Cytosponge-TFF3 test, with endoscopy if positive
- Usual care (control, n = 6,531): Standard management of reflux; endoscopy only if requested by the general practitioner
- People
- Fitzgerald RC, BEST3 Trial team