Improved detection of Barrett oesophagus can help prevent progression to oesophageal adenocarcinoma. Now, a trial of a non-endoscopic test, Cytosponge-trefoil factor 3 (TFF3), has demonstrated improved detection of Barrett oesophagus compared with standard management.
Cytosponge-TFF3 is a device that can be used in the primary care setting. The device is swallowed and collects oesophageal cells, and an in vitro test for the biomarker TFF3 identifies intestinal metaplasia. “This is a new test and before this there had been no randomized trial data out there to show that this approach can diagnose more cases of Barrett oesophagus and early cancer,” says author Rebecca Fitzgerald.
The randomized controlled trial was conducted in 109 general practice clinics in England. Eligible participants (those aged 50 years or older and who had been prescribed acid-suppressant therapy for at least 6 months in the previous year) were randomly assigned to the intervention group (n = 6,983), who were offered the Cytosponge-TFF3 procedure, or the control group (n = 6,531), who instead had an endoscopy if referred by the general practitioner. After accounting for those who did not meet all eligibility criteria or withdrew from the study, there were 6,834 in the intervention group and 6,388 in the control group.
Of 1,654 participants who successfully swallowed the Cytosponge device, 221 (13%) tested positive for TFF3 and underwent endoscopy, with 131 (8%) being diagnosed with Barrett oesophagus or cancer. In the intervention group and control group, 140 (2%) participants and 13 (<1%) participants, respectively, were diagnosed with Barrett oesophagus during an average of 12 months follow-up (overall rate ratio 10.2 (95% CI 5.8–18.1) and 10.6 (95% CI 6.0–18.8; P < 0.0001) when adjusted for cluster randomization).
improved detection of Barrett oesophagus compared with standard management
Thus, offering Cytosponge-TFF3 increased the diagnosis of Barrett oesophagus by tenfold compared with usual medication and endoscopy referral as determined by the clinician. The next steps for clinical implementation include evaluating the health economics, determining how Cytosponge-TFF3 fits into clinical care pathways, and investigating additional biomarkers for surveillance, according to Fitzgerald. “The COVID-19 situation is accelerating adoption of this technology as it is less aerosol-generating than endoscopy and can be performed by a single member of staff in an office setting outside of the hospital.”
Fitzgerald, R. et al. Cytosponge-trefoil factor 3 versus usual care to identify Barrett’s oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial. Lancet 396, 333–344 (2020)
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Hindson, J. Detecting Barrett oesophagus using Cytosponge. Nat Rev Gastroenterol Hepatol 17, 596 (2020). https://doi.org/10.1038/s41575-020-00359-4