Abstract

Biliary tract cancer (BTC) has poor prognosis and its mortality is higher than other gastrointestinal malignancies. Early diagnosis of BTC is important to decrease the mortality. Vimentin-positive circulating tumor cells (V-CTCs) are a good candidate for diagnostic biomarkers. However, there are limited studies regarding the role of V-CTCs as diagnostic and prognostic biomarkers in BTC patients. The aim of this study was to evaluate the diagnostic efficacy of V-CTCs between BTC and benign biliary disease (BBD) and determine the prognostic value of V-CTCs in BTC patients. We recruited 69 participants who has BTCs and BBDs from a single tertiary referral center between June 2018 and February 2021. We analyzed CTCs and V-CTCs using peripheral blood by CD-PRIMETM system, which is a commercialized version of the FAST disc (Clinomics, Ulsan, Korea). CTCs were detected in 62 of 69 (90%) patients. CTC count > 40/ml blood (20% Vs 55.8%, p=0.039), V-CTC > 15/ml blood (10% Vs 57.7%, p=0.005) and V-CTC/CTC ratio > 40% (10% Vs 48.1%, p=0.025) were significantly different between BTCs and BBDs. And two or more of these parameters (10% Vs 61.5%, p=0.002) increased the accuracy of distinguishing between BTCs and BBDs. Moreover, the combination of circulating tumor markers with elevated CA19-9 and biopsy, increased the accuracy (10% Vs 90.4%, p=0.000). Combination of circulating tumor markers with elevated CA19-9 (10%, Vs 84.8%, p=0.000) and biopsy (10% Vs 87.9%, p=0.000) was also distinguished between BBD and resectable BTC. In terms of prognosis, V-CTC > 50/ml blood was a significantly influencing factor of survival (140 days Vs 253 days, p=0.008). The combination of circulating tumor markers with elevated CA19-9 and/or biopsy may discriminate early stage of BTC from BBD, and V-CTC could determine future prognosis in patients with BTC.

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