Percutaneous transhepatic cholangioscopy for complex biliary lesions: multicenter real-world diagnostic performance and safety study

Abstract Purpose To evaluate the diagnostic performance of operator global impression and prespecified endoluminal visual criteria during percutaneous transhepatic cholangioscopy in patients with complex biliary disease and inconclusive imaging and/or endoscopic findings, using histopathology as the reference standard, and to describe adverse events. Materials and methods This retrospective multicenter cohort included consecutive diagnostic PTCS (percutaneous transhepatic cholangioscopy) procedures performed between January 2018 and July 2025 at tertiary referral centers. Procedures, where the objective of treatment was lithiasis, were excluded in order to define a cohort in which imaging and endoscopic evaluation prior to the procedure were inconclusive or failed endoscopic retrograde access, prompting direct endoluminal evaluation with targeted sampling. Operator global impression (benign vs malignant) and five prespecified visual criteria were recorded during cholangioscopy and compared with classifiable histopathology. Diagnostic performance metrics and exploratory combined-rule analyses were calculated. Adverse events were classified using the modified CIRSE system. Results Sixty-eight diagnostic PTCS procedures were analyzed (median age, 66.5 years; 41/68 male). Malignancy was confirmed in 57/68 procedures (83.8%). Operator global impression demonstrated 84.2% sensitivity, 90.9% specificity, and 85.3% accuracy, with positive and negative predictive values of 98.0% and 52.6%, respectively. Among individual visual criteria, an infiltrative appearance showed high specificity for malignancy (90.9%) and was strongly associated with malignant histopathology (odds ratio [OR], 13.75; p = 0.006). Tumor vessels were also associated with malignancy (OR, 4.57; p = 0.044). Adverse events occurred in 10/68 procedures (14.7%), including CIRSE grade I events in 2, grade II in 5, and grade IV in 3. Conclusions In this multicenter, referral-enriched diagnostic cohort, operator impression and selected visual patterns correlated with histopathology. Most adverse events were low grade, supporting standardized prophylaxis, drainage strategies, and post-procedure monitoring for antegrade cholangioscopy.