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Background <p>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).</p> Methods <p>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.</p> Results <p>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, <i>p</i> = 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, <i>p </i>= 0.008).</p> Conclusions <p>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.</p>

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Endoscopic liquid biopsy of bile: superior diagnostic and prognostic performance of bile-derived exosomal miR-21-5p for biliary tract cancers

  • 期刊论文

  • 发表日期：

    2025年4月23日

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  • Michihiro Yoshida,
  • Tadashi Toyohara,
  • Yasuki Hori,
  • Akihisa Kato,
  • Hidenori Sahashi,
  • Kayoko Kuno,
  • Akihisa Adachi,
  • Yusuke Kito,
  • Kenji Urakabe,
  • Kazuki Hayashi,
  • Itaru Naitoh,
  • Fumihiro Okumura,
  • Hiromu Kondo,
  • Makoto Natsume,
  • Naruomi Jinno,
  • Kenta Kachi,
  • Hiromi Kataoka,
  • Yasuhito Tanaka

摘要

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.