RecruitingNot ApplicableNCT06816615

Diagnosis and Percutaneous Treatment of Biliary Tract Diseases


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

24 participants

Start Date

Oct 14, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • Radiological diagnosis of indeterminate gallstones or stenosis of the bile ducts not eligible for endoscopic treatment and/or previous failed endoscopic treatment
  • Good liver function (hemoglobin, hematocrit, GOT, GPT, GGT within normal ranges)
  • Age over 18
  • Obtaining informed consent

Exclusion Criteria1

  • presence of severe untreatable coagulopathies

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Interventions

PROCEDUREPercutaneous 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.


Locations(1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, Italy

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NCT06816615


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