SynthesisMolecular diagnosis & therapy2026
Bile Cell-Free DNA as a Tumor-Proximal Source for Molecular Profiling of Biliary Tract Cancer: A Systematic Review and Meta-Analysis.
Synthesis in Molecular diagnosis & therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
6 authors.
Funding
Abstract
backgroundMolecular profiling is increasingly required for treatment selection in advanced biliary tract cancer, yet tumor tissue is often insufficient and plasma circulating tumor DNA has limited yield. Because bile directly contacts the biliary epithelium and is obtainable during routine biliary interventions, bile cell-free DNA (cfDNA) may provide a tumor-proximal molecular profiling source.
objectiveWe systematically reviewed and quantitatively synthesized bile cfDNA detection and profiling in biliary tract cancer.
methodsPubMed, EMBASE, and the Cochrane Library were searched from inception to 13 October, 2025 for studies that included at least ten patients with suspected or confirmed biliary tract cancer and extractable bile cfDNA outcomes. Pooled proportions were estimated using random-effects models with Freeman-Tukey double-arcsine transformation. Bile-versus-plasma detection was compared using pooled log risk ratios. Heterogeneity was quantified by I
resultsEight studies including 271 patients with biliary tract cancer were included. After excluding two cohorts with 100% detection, the conservative pooled bile cfDNA molecular detection rate was 59.1% (95% confidence interval [CI] 49.0-68.7; I
conclusionsBile cfDNA showed higher molecular detection than plasma cfDNA and supported molecular profiling when tumor tissue was insufficient, but detection and endpoint heterogeneity limit its use as a stand-alone diagnostic test. Its role is best defined as opportunistic molecular profiling during indicated biliary procedures, pending prospective multicenter validation with standardized protocols. PROTOCOL REGISTRATION: PROSPERO CRD420251250742 (registered prospectively prior to study conduct).
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Registered trials
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