Diagnosis and Percutaneous Treatment of Biliary Tract Diseases

Condition(s) studied

Investigational drug(s) / intervention(s)

Percutaneous cholangioscopic-assisted treatment: The intervention administered is a percutaneous colangioscopic assisted technique that uses endoscopic Spyglass system. The endoscopic Spyglass system is designed to provide direct viewing and to guide both optical devices and accessories for lithotripsy in case of litiasic pathology and is equipped with a suitable bioptic clamp in case of biopsy collection. The use of the digital Spyglass catheter involves the preliminary percutaneous puncture of the bile ducts with a right, left or combined approach, and the subsequent execution of a cholangiographic study. Additional treatment sessions may be performed every 15-20 days in case of residual lithiasis. At the end of each session, an internal-external transeptic percutaneous drainage (ptbd) of adequate caliber (8-14 fr) is left in place to monitor any complications and maintain a route of access for sequential treatments.

Study summary

This study aims to implement and optimize the treatment of bile duct diseases in participants not eligible for endoscopic treatment using the Spyglass system, a system suitable for diagnostic and therapeutic endoscopic procedures in the pancreatic-biliary system, including the hepatic ducts.

The main question it aims to answer is:

\- Can the percutaneous cholangioscopic assisted technique resolve the biliary litiasis and/or perform endobiliary biopsies in less time than the traditional technique?

Participants will undergo a colangioscopic-assisted treatment using the SpyGlass mini-endoscopic system at the Addomino-pelvic diagnostic and interventional radiology UOC of the Bologna University Hospital.

Eligibility

Primary outcome measure(s)

• Number of treatments — From enrollment to the end of treatment at 7 years
  Number of treatments
• Duration of drainage — From enrollment to the end of treatment at 7 years
  Duration of drainage
• Relapse free interval — From enrollment to the end of treatment at 7 years
  Relapse free interval
• Duration of hospitalization — From enrollment to the end of treatment at 7 years
  Duration of hospitalization

Trial sites (1)

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