To investigate the efficacy and safety of direct visualization diagnosis andmanagement of complex biliary diseases via percutaneous transhepatic choledochoscopy.

A retrospective cohort study was conducted on patients who underwent percutaneous transhepatic diagnostic or therapeutic procedures at the Department of Hepatobiliary and Liver Transplantation Surgery, Nanjing Drum Tower Hospital Affiliated to Nanjing University, from Jan. 2024 to Dec. 2025. Outcome measures included surgery success rate, complication incidence, biliary biopsy success rate, pathological concordance rate, and residual biliary stone rate.

A total of 16 patients were enrolled. Among them, 9 (9/16, 56.3%) underwent choledochoscopy with biopsy, 6 (6/16, 37.5%) received lithotripsy and stone extraction, and 3 (3/16, 18.8%) underwent balloon dilation for biliary stricture—with 1 (1/3, 33.3%) of the latter each group combining biopsy and stone extraction. 11 (11/16, 68.8%) patients were achieved predefined surgical plan.5 (5/9, 55.6%) cases were obtained tissue samples. Notably, 2 (2/16, 12.5%) patients preoperatively diagnosed with hilar cholangiocarcinoma were reclassified via biopsy as having hepatocellular carcinoma with biliary tumor thrombi, leading to a complete revision of their treatment regimens. Operative times varied by procedure: choledochoscopy with biopsy (44.2 ± 18.0 min), balloon dilation with stenting (38.3±5.8 min), and lithotripsy with stone extraction (76.7 ± 22.7 min). Mean intraoperative blood loss was 9.1±8.4 ml, with no patients requiring blood transfusion, interventional hemostasis, or surgical hemostasis. 1 patient developed minor bile leakage from an intra-abdominally displaced drainage tube, which resolved following endoscopic retrograde cholangiopancreatography (ERCP). No patients were transferred to the intensive care unit due to complications, and there were no cases of tumor seeding along the sinus tract and mortality case.

Percutaneous transhepatic choledochoscopy under direct visualization is a safe and feasible approach for diagnosing and treating complex biliary diseases. Sinus tract establishment remains a key technical challenge. Integration of multidisciplinary equipment is recommended, and direct-visualization biopsy via choledochoscopy provides a reliable pathway for definitive pathological diagnosis.