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Acceptability and Adequacy of a Non-endoscopic Cell Collection Device for Diagnosis of Barrett's Esophagus: Lessons Learned

机译:Acceptability and Adequacy of a Non-endoscopic Cell Collection Device for Diagnosis of Barrett's Esophagus: Lessons Learned

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Background Endoscopic screening for Barrett's esophagus (BE) is common, costly, and underperformed in at-risk people. A non-endoscopic cell collection device can be used to collect esophageal cells, enabling BE screening. Aims This study assessed the acceptability and adequacy of a commercial non-endoscopic cell collection device in a US population. Methods Six sites enrolled patients with confirmed BE or heartburn/regurgitation for >= 6 months. Patients underwent administration of the device, consisting of a sponge encapsulated in a capsule. The capsule dwelled in the stomach for 7.5 min and was retracted via an attached suture. An adequate sample was >= 1 columnar cell by HE staining. Sample quality was rated using a 0-5 scale, with 0 = no columnar cells and 5 = plentiful groups. Trefoil Factor 3 (TFF3) staining was performed. Accuracy was assessed using esophagogastroduodenoscopy (EGD)/biopsy as the gold standard. Results Of 191 patients, 99.5 successfully swallowed the device. Overall sample adequacy was 91 (171/188), with 84 (158/188) high quality. The detachment rate was 2/190 (1). Overall sensitivity, specificity, and accuracy of the assay with TFF3 staining were 76, 77, and 76. Sensitivity, specificity, and accuracy for >= 3 cm BE were 86, 77, and 82. Asked if willing to repeat the procedure, 93 would, and 65 indicated a preference for the device over EGD. Conclusions This study demonstrated a high rate of sample adequacy and promising acceptability of this non-endoscopic sampling device in a US population. Diagnostic characteristics suggest that non-endoscopic assessment of BE deserves further development as an alternative to endoscopy.

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