cytosponge in screening for Barrett's oesophagus

Last edited 05/2023 and last reviewed 08/2023

Cytosponge

• Cytosponge is a non-endoscopic diagnostic tool that was developed to detect Barrett's oesophagus in patients with reflux symptoms
  
  
  • consists of a tethered capsule that is swallowed in a primary or secondary care office setting and collects oesophageal cells, which can be assessed for morphology and immunohistochemical biomarkers of intestinal metaplasia (TFF3) and dysplasia (atypia and p53) (1)
    
    
• non-endoscopic oesophageal cell collection device known as the Cytosponge, coupled with a biomarker test for trefoil factor 3 (TFF3), has been shown to increase detection of Barrett's oesophagus ten times over the current standard of care (2)
  
  
• the BEST3 study is summarised (3):
  • patients were randomly assigned (per practice or at the individual patient level) to the usual care group or the intervention group
    • in the intervention group
      • 2679 (39%) expressed an interest in undergoing the Cytosponge-TFF3 procedure
        • of these, 1750 (65%) met all of the eligibility criteria on telephone screening and underwent the procedure
        • most of these participants (1654 [95%]; median age 69 years) swallowed the Cytosponge successfully and produced a sample
        • 231 (3%) of 6834 participants had a positive Cytosponge-TFF3 result and were referred for an endoscopy
        • patients who declined the offer of the Cytosponge-TFF3 procedure and all participants in the usual care group only had an endoscopy if deemed necessary by their general practitioner
        • during an average of 12 months of follow-up, 140 (2%) of 6834 participants in the intervention group and 13 (<1%) of 6388 participants in the usual care group were diagnosed with Barrett's oesophagus
        • nine (<1%) of 6834 participants were diagnosed with dysplastic Barrett's oesophagus (n=4) or stage I oesophago-gastric cancer (n=5) in the intervention group, whereas no participants were diagnosed with dysplastic Barrett's oesophagus or stage I gastro-oesophageal junction cancer in the usual care group
        • among 1654 participants in the intervention group who swallowed the Cytosponge device successfully, 221 (13%) underwent endoscopy after testing positive for TFF3 and 131 (8%, corresponding to 59% of those having an endoscopy) were diagnosed with Barrett's oesophagus or cancer.
        • one patient had a detachment of the Cytosponge from the thread requiring endoscopic removal, and the most common side-effect was a sore throat in 63 (4%) of 1654 participants
  • the study authors concluded that:
    • in patients with gastro-oesophageal reflux, the offer of Cytosponge-TFF3 testing results in improved detection of Barrett's oesophagus

Reference:

• di Pietro M, Modolell I, O'Donovan M, Price C, Pilonis ND, Debiram-Beecham I, Fitzgerald RC. Use of Cytosponge as a triaging tool to upper gastrointestinal endoscopy during the COVID-19 pandemic. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):805-806. doi: 10.1016/S2468-1253(20)30242-9.
• Pilonis ND, Killcoyne S, Tan WK, O'Donovan M, Malhotra S, Tripathi M, Miremadi A, Debiram-Beecham I, Evans T, Phillips R, Morris DL, Vickery C, Harrison J, di Pietro M, Ortiz-Fernandez-Sordo J, Haidry R, Kerridge A, Sasieni PD, Fitzgerald RC. Use of a Cytosponge biomarker panel to prioritise endoscopic Barrett's oesophagus surveillance: a cross-sectional study followed by a real-world prospective pilot. Lancet Oncol. 2022 Feb;23(2):270-278.
• Fitzgerald RC, di Pietro M, O'Donovan M, Maroni R, Muldrew B, Debiram-Beecham I, Gehrung M, Offman J, Tripathi M, Smith SG, Aigret B, Walter FM, Rubin G; BEST3 Trial team; Sasieni P. Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial. Lancet. 2020 Aug 1;396(10247):333-344