Journal of gastroenterology · 2025
Endoscopic liquid biopsy of bile: superior diagnostic and prognostic performance of bile-derived exosomal miR-21-5p for biliary tract cancers.
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Yoshida Michihiro, Toyohara Tadashi, Hori Yasuki, Kato Akihisa, Sahashi Hidenori, Kuno Kayoko, Adachi Akihisa, Kito Yusuke, Urakabe Kenji, Hayashi Kazuki, Naitoh Itaru, Okumura Fumihiro, Kondo Hiromu, Natsume Makoto, Jinno Naruomi, Kachi Kenta, Kataoka Hiromi, Tanaka Yasuhito
Аннотация
BACKGROUND: Compared to peripheral blood, bile as a microenvironment within the biliary tract is expected to contain a higher concentration of tumor-associated factors secreted directly by primary biliary tumors, making it a promising source for tumor analysis. This study explores the diagnostic and prognostic utility of exosomal miR-21-5p in bile and serum for biliary tract cancers (BTCs).
METHODS: miR-21-5p expression was analyzed in 110 bile samples (55 BTC, 55 controls) collected during endoscopic retrograde cholangiopancreatography using qRT-PCR. The diagnostic and prognostic performances of miR-21-5p levels in bile and serum were evaluated. To enhance clinical applicability, we also developed a novel diagnostic parameter termed "miR-21-5p bile/serum (B/S) ratio", calculated by determining the ratio of bile to serum miR-21-5p within individuals.
RESULTS: miR-21-5p expression was significantly elevated in both the bile and serum of patients with BTC. Bile miR-21-5p showed superior diagnostic performance (AUC: 0.913) over serum miR-21-5p (AUC: 0.628) and CA19-9 (AUC: 0.793). Prognostically, a higher bile miR-21-5p was associated with poorer overall survival and was identified as an independent predictor (HR: 2.446, p = 0.002), whereas serum miR-21-5p lacked significant prognostic value. B/S ratio also showed high diagnostic accuracy when ≥ 2 (AUC: 0.870), and a B/S ratio ≥ 13 was associated with significantly poorer overall survival and found as an independent prognostic predictor (HR: 2.554, p = 0.008).
CONCLUSIONS: Bile miR-21-5p and miR-21-5p B/S ratio are promising biomarkers for BTC diagnosis and prognosis that outperform traditional markers, highlighting the potential of bile-derived miRNAs for clinical use.
METHODS: miR-21-5p expression was analyzed in 110 bile samples (55 BTC, 55 controls) collected during endoscopic retrograde cholangiopancreatography using qRT-PCR. The diagnostic and prognostic performances of miR-21-5p levels in bile and serum were evaluated. To enhance clinical applicability, we also developed a novel diagnostic parameter termed "miR-21-5p bile/serum (B/S) ratio", calculated by determining the ratio of bile to serum miR-21-5p within individuals.
RESULTS: miR-21-5p expression was significantly elevated in both the bile and serum of patients with BTC. Bile miR-21-5p showed superior diagnostic performance (AUC: 0.913) over serum miR-21-5p (AUC: 0.628) and CA19-9 (AUC: 0.793). Prognostically, a higher bile miR-21-5p was associated with poorer overall survival and was identified as an independent predictor (HR: 2.446, p = 0.002), whereas serum miR-21-5p lacked significant prognostic value. B/S ratio also showed high diagnostic accuracy when ≥ 2 (AUC: 0.870), and a B/S ratio ≥ 13 was associated with significantly poorer overall survival and found as an independent prognostic predictor (HR: 2.554, p = 0.008).
CONCLUSIONS: Bile miR-21-5p and miR-21-5p B/S ratio are promising biomarkers for BTC diagnosis and prognosis that outperform traditional markers, highlighting the potential of bile-derived miRNAs for clinical use.