Outcomes of percutaneous transluminal biopsy of biliary lesions using a dedicated forceps system.

Background Distinction between benign and malignant biliary obstruction is always challenging. Purpose To evaluate outcomes of percutaneous transluminal biopsy of biliary strictures using a dedicated forceps system. Material and Methods This prospective, single-center, single-arm study, included 29 consecutive patients (17 men [56.6%]; mean age = 60 ± 9 years), who underwent 30 transluminal biopsies during percutaneous transhepatic biliary drainage (PTBD) due to obstructive jaundice, between September 2014 and January 2017, using a transluminal biliary access and biopsy forceps set. The study's primary efficacy endpoint was technical success and the primary safety endpoint was the procedure-related major complications rate. The study's secondary endpoints were procedure-related minor complication rate, sensitivity, specificity, and diagnostic accuracy for the characterization of malignancy. Results Tissue samples allowed histological diagnosis in 27/30 procedures (technical success rate 90.0%), as in three cases (10.0%) the sample was characterized as non-diagnostic: one case was suspicious for pancreatic cancer and two cases were cholangiocarcinoma. In one case, biopsy was successfully repeated. The diagnosis was cholangiocarcinoma in 16 cases (53.3%), colorectal metastasis in three cases (10%), pancreatic adenocarcinoma in three cases (10.0%), and inflammation in five cases (16.6%). There were two false-negative cases of inflammation proven to be cholangiocarcinoma, resulting in sensitivity of 91.67%, specificity of 100%, and accuracy of 92.59%. No major complications were noted. There were four cases of hemobilia (13%) which auto-resolved within 48 h. Conclusion Percutaneous transluminal biopsy of biliary strictures during PTBD using the specific forceps system was proven safe and resulted in high technical success and diagnostic accuracy rates.