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

Distinction between benign and malignant biliary obstruction is always challenging.

To evaluate outcomes of percutaneous transluminal biopsy of biliary strictures using a dedicated forceps system.

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.

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.

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.