The Cytosponge, a novel, minimally invasive cell sampling device, paired with immunohistochemical staining for the biomarker Trefoil Factor 3, safely and accurately identified patients with Barrett’s esophagus, according to new research data.
Rebecca C. Fitzgerald
Fitzgerald and colleagues performed a case-control study (the BEST2 Study) involving 647 patients with BE receiving a monitoring endoscopy and 463 controls referred to endoscopy for dyspepsia and reflux symptoms at 11 U.K. hospitals from July 2011 to December 2013. All participants swallowed a Cytosponge (Covidien) before endoscopy and the researchers assessed the safety, acceptability and accuracy of the Cytospone-TFF3 assay compared with endoscopy and biopsy.
Among the 93.9% of participants who successfully swallowed the Cytosponge, three had serious adverse events, but they were unrelated to the device, and 16.7% had a related adverse event (bleeding from a Cytosponge abrasion), but they did not require intervention and were comparable to those seen with biopsy.
Using a visual analogue scale, patients preferred the Cytosponge compared with endoscopy overall, especially those not sedated for endoscopy (both P < .001); 34.5% of patients rated the procedures equally and 37.8% preferred the Cytosponge.
Overall, the Cytosponge-TFF3 test had 79.9% (95% CI, 76.4-83) sensitivity and 92.4% (95% CI, 89.5-94.7) specificity. Sensitivity increased with circumferential length of the Barrett’s segment up to 87.2% (95% CI, 83-90.6%), and there was no loss of sensitivity in patients with dysplasia. Sensitivity increased further to 89.7% (95% CI, 82.3-94.8) in the 107 patients who swallowed the device a second time when both test results were considered together.
“While the case-control design was appropriate to obtain accuracy data with narrow confidence intervals, this design has known limitations in terms of the ability to generalize the data to the primary care population consulting for reflux symptoms,” the researchers wrote. “In addition, the acceptability data were limited to a single measure.”
“This technology could alter the way that we test patients with heartburn and ultimately reduce the number of people being diagnosed with advanced cancer of the esophagus,” Fitzgerald said. – by Adam Leitenberger
Disclosure: Fitzgerald reports having received programmatic funding from the Medical Research Council and infrastructure support from the Biomedical Research Center and the Experimental Medicine Center, and she and other researchers are named inventors on patents pertaining to the Cytosponge and related assays. Please see the full study for a list of all other authors’ relevant financial disclosures.