Abstract
BackgroundBarrett's esophagus (BE) is a commonly undiagnosed condition that predisposes to esophageal adenocarcinoma. Routine endoscopic screening for BE is not recommended because of the burden this would impose on the health care system. The objective of this study was to determine whether a novel approach using a minimally invasive cell sampling device, the Cytosponge, coupled with immunohistochemical staining for the biomarker Trefoil Factor 3 (TFF3), could be used to identify patients who warrant endoscopy to diagnose BE.Methods and FindingsA case–control study was performed across 11 UK hospitals between July 2011 and December 2013. In total, 1,110 individuals comprising 463 controls with dyspepsia and reflux symptoms and 647 BE cases swallowed a Cytosponge prior to endoscopy. The primary outcome measures were to evaluate the safety, acceptability, and accuracy of the Cytosponge-TFF3 test compared with endoscopy and biopsy.In all, 1,042 (93.9%) patients successfully swallowed the Cytosponge, and no serious adverse events were attributed to the device. The Cytosponge was rated favorably, using a visual analogue scale, compared with endoscopy (p < 0.001), and patients who were not sedated for endoscopy were more likely to rate the Cytosponge higher than endoscopy (Mann-Whitney test, p < 0.001). The overall sensitivity of the test was 79.9% (95% CI 76.4%–83.0%), increasing to 87.2% (95% CI 83.0%–90.6%) for patients with ≥3 cm of circumferential BE, known to confer a higher cancer risk. The sensitivity increased to 89.7% (95% CI 82.3%–94.8%) in 107 patients who swallowed the device twice during the study course. There was no loss of sensitivity in patients with dysplasia. The specificity for diagnosing BE was 92.4% (95% CI 89.5%–94.7%). The case–control design of the study means that the results are not generalizable to a primary care population. Another limitation is that the acceptability data were limited to a single measure.ConclusionsThe Cytosponge-TFF3 test is safe and acceptable, and has accuracy comparable to other screening tests. This test may be a simple and inexpensive approach to identify patients with reflux symptoms who warrant endoscopy to diagnose BE.
Highlights
It is estimated that 5% to 15% of adults in the Western world suffer from reflux symptoms [1], and this is the commonest physician diagnosis for gastrointestinal consultations, accounting for 9 million physician consultations in the US in 2009 [2]
The objective of this study was to determine whether a novel approach using a minimally invasive cell sampling device, the Cytosponge, coupled with immunohistochemical staining for the biomarker Trefoil Factor 3 (TFF3), could be used to identify patients who warrant endoscopy to diagnose Barrett’s esophagus (BE)
We recently demonstrated that analysis for TP53 mutations in Cytosponge samples can be used to diagnose high grade dysplasia (HGD) when compared with samples from patients without BE and patients with BE who had never developed dysplasia over a median follow-up of 6 y [25]
Summary
It is estimated that 5% to 15% of adults in the Western world suffer from reflux symptoms [1], and this is the commonest physician diagnosis for gastrointestinal consultations, accounting for 9 million physician consultations in the US in 2009 [2]. Many individuals with recurrent reflux symptoms do not consult their doctor and remain uninvestigated. Endoscopy is performed to justify and tailor the prescription of acid-suppressant medications, to identify early esophageal adenocarcinoma that has not yet advanced sufficiently to cause weight loss or other alarm symptoms, and to diagnose the pre-malignant precursor for esophageal adenocarcinoma called Barrett’s esophagus (BE). A diagnosis of BE will be found in up to 25% of those undergoing endoscopy, depending on the severity of the symptoms and the age and sex of the individual [3,4,5,6,7]. The importance of BE lies in its potential to progress to esophageal adenocarcinoma through intermediate dysplastic stages. Barrett’s esophagus (BE) is a commonly undiagnosed condition that predisposes to esophageal adenocarcinoma. The objective of this study was to determine whether a novel approach using a minimally invasive cell sampling device, the Cytosponge, coupled with immunohistochemical staining for the biomarker Trefoil Factor 3 (TFF3), could be used to identify patients who warrant endoscopy to diagnose BE
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