ArticleGut2022
Next-generation sequencing of bile cell-free DNA for the early detection of patients with malignant biliary strictures.
Article in Gut, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07007832 (The Diagnostic Value of Bile-based Omics Analysis for Indeterminate Biliary Strictures), which is not on this map. Cited by 60 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Diagnostic Value of Bile-based Omics Analysis for Indeterminate Biliary Strictures
Who cites it
60 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Bile Cell-Free DNA as a Tumor-Proximal Source for Molecular Profiling of Biliary Tract Cancer: A Systematic Review and Meta-Analysis.Molecular diagnosis & therapy · 2026Pooled it
- From infection to cholangiocarcinoma: Why opisthorchiids break these rules.One health (Amsterdam, Netherlands) · 2026Review
- Next Generation Sequencing for the Differentiation of Benign and Malignant Biliary Strictures.Liver international : official journal of the International Association for the Study of the Liver · 2026Article
- Bio-Memristor Based on Clinical Bile Samples: A Proof-of-Concept Pilot Study for Detection of Gallbladder Cancer.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Extracellular vesicle biomarkers in pancreatic ductal adenocarcinoma: from bulk detection to single-extracellular vesicle profiling and endoscopic liquid biopsy.Journal of gastroenterology · 2026Review
- DNA/RNA-Based Next-Generation Sequencing Improves the Early Diagnosis and Management of Neoplastic Bile Duct Strictures: A 6-Year, Prospective, Multi-Institutional, Real-Time Study.Gastroenterology · 2026Article
- Emerging omics diagnosis of perihilar cholangiocarcinoma.Journal of gastroenterology · 2026Article
- Comprehensive Gene Panel Analysis of Biliary Tract Cancer Using Next-Generation Sequencing of Endoscopic Transpapillary Brushing/Biopsy/Aspiration Specimens: A Narrative Review.Diagnostics (Basel, Switzerland) · 2026Review
- Diagnostic and Prognostic Values of Bile Biomarkers for Malignant Biliary Stenosis.Liver international : official journal of the International Association for the Study of the Liver · 2026Article
- Molecular endoscopy with next-generation sequencing improves diagnosis of cholangiocarcinoma in patients with extrahepatic biliary strictures.JHEP reports : innovation in hepatology · 2026Article
- Circulating Tumor DNA as a Biomarker in Pancreatic Cancer: Clinical Applications and Challenges.Clinical and translational gastroenterology · 2026Review
- Liquid biopsy epigenetics: establishing a molecular profile based on cell-free DNA.Molecular oncology · 2026Review
- Evolving techniques to optimize ERCP-based sampling and evaluation of malignant biliary strictures.Gastroenterology report · 2026Review
- Ultra-low-pass whole-genome sequencing of bile cfDNA in patients with biliary strictures.eGastroenterology · 2026Article
- Cholangiocarcinoma 2026: status quo, unmet needs and priorities.Nature reviews. Gastroenterology & hepatology · 2026Review
- A guide for establishing patient-derived organoids from bile samples obtained during endoscopic procedures and performing gene expression knockdown.Frontiers in cell and developmental biology · 2026Article
- Present and future of liver transplantation for cholangiocellular carcinoma: moving toward personalized multiparametric transplantability patterns.Transplant international : official journal of the European Society for Organ Transplantation · 2026Review
- Liquid Biopsy and Automated Next-Generation Sequencing: Achieving Results in 27 Hours Within a Community Setting.Diagnostics (Basel, Switzerland) · 2025Article
- Two scopes, one mission: An integrated approach of endoscopic retrograde cholangiopancreatography and endoscopic ultrasound to biliary strictures.World journal of gastroenterology · 2025Review
- Article
Corrections and comments
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Authors and funding
32 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveDespite significant progresses in imaging and pathological evaluation, early differentiation between benign and malignant biliary strictures remains challenging. Endoscopic retrograde cholangiopancreatography (ERCP) is used to investigate biliary strictures, enabling the collection of bile. We tested the diagnostic potential of next-generation sequencing (NGS) mutational analysis of bile cell-free DNA (cfDNA).
designA prospective cohort of patients with suspicious biliary strictures (n=68) was studied. The performance of initial pathological diagnosis was compared with that of the mutational analysis of bile cfDNA collected at the time of first ERCP using an NGS panel open to clinical laboratory implementation, the Oncomine Pan-Cancer Cell-Free assay.
resultsAn initial pathological diagnosis classified these strictures as of benign (n=26), indeterminate (n=9) or malignant (n=33) origin. Sensitivity and specificity of this diagnosis were 60% and 100%, respectively, as on follow-up 14 of the 26 and eight of the nine initially benign or indeterminate strictures resulted malignant. Sensitivity and specificity for malignancy of our NGS assay, herein named Bilemut, were 96.4% and 69.2%, respectively. Importantly, one of the four Bilemut false positives developed pancreatic cancer after extended follow-up. Remarkably, the sensitivity for malignancy of Bilemut was 100% in patients with an initial diagnosis of benign or indeterminate strictures. Analysis of 30 paired bile and tissue samples also demonstrated the superior performance of Bilemut.
conclusionImplementation of Bilemut at the initial diagnostic stage for biliary strictures can significantly improve detection of malignancy, reduce delays in the clinical management of patients and assist in selecting patients for targeted therapies.
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