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Diagnosis and Percutaneous Treatment of Biliary Tract Diseases

NCT06816615 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-02-10

No results posted yet for this 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.

Conditions

  • Gallstone
  • Biliary Stricture
  • Biliary Diseases

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Alberta Cappelli, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-14
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06816615 on ClinicalTrials.gov