Diagnosis and Percutaneous Treatment of Biliary Tract Diseases Using SpyGlass System

What this Trial Is About

Researchers are evaluating a percutaneous cholangioscopic assisted technique using the Spyglass mini-endoscopic system to treat bile duct diseases in participants who are not eligible for traditional endoscopic treatment. This study aims to determine whether this new approach can clear biliary stones and perform endobiliary biopsies more quickly than conventional methods. The study is a non-pharmacological, prospective, single-center interventional trial conducted at the Bologna University Hospital. Participants will undergo the percutaneous cholangioscopic-assisted treatment, which involves a preliminary puncture of the bile ducts followed by a cholangiographic study using the Spyglass system. This system provides direct viewing and allows guided lithotripsy or biopsy collection. Multiple treatment sessions may be scheduled every 15-20 days if residual stones remain, with percutaneous drainage left in place after each session to monitor complications and maintain access. During the study, participants will receive clinical laboratory monitoring and imaging tests as needed, with follow-up visits at 3, 6, 12, 24, and 36 months post-treatment. Researchers will collect clinical data and review anonymized imaging to evaluate outcomes such as number of treatments, duration of drainage, relapse-free interval, and length of hospitalization. The total study duration includes a 24-month enrollment phase followed by a 36-month follow-up period.

Diagnosis and Percutaneous Treatment of Biliary Tract Diseases