Evaluating Next-Generation Sequencing to Improve Diagnosis of Bile Duct Tumors

What this Trial Is About

Researchers are investigating a specific next-generation sequencing NGS panel that targets dysplasia and cholangiocarcinoma CCA to improve the accuracy of diagnosing biliary tract narrowing. This exploratory study aims to enhance the sensitivity of histological and cytological exams for biliary tract stenosis. The study is conducted by the IRCCS Azienda Ospedaliero-Universitaria di Bologna and plans to enroll 50 patients undergoing biliary tract surgery. Participants will be patients who undergo biliary tract resection as part of their standard medical care, including procedures such as hepatectomy or duodenocephalopancreasectomy. Tissue samples collected during surgery will be processed and analyzed at the Pathological Anatomy unit using NGS technology. The 2-micron sections prepared from paraffin blocks of surgical tissue will be used for the sequencing investigations. Throughout the 36-month study period, clinical, serological, and imaging data relevant to the analyses will be collected. The primary outcome is to identify an NGS panel specific to dysplasia and CCA during the enrollment phase, which lasts up to 30 months. Participants will be closely monitored as part of their usual care, and the study will gather data to evaluate the diagnostic value of NGS in biliary tract tumors.

Diagnostic Value of Next-Generation Sequencing Analysis in Biliary Tract Tumours