Status:
COMPLETED
Cholangioscopy in Primary Sclerosing Cholangitis (PSC)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Primary Sclerosing Cholangitis (PSC)
Eligibility:
All Genders
18+ years
Brief Summary
To demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard endoscopic retrograde cholangiopancreatography (ERCP) with brushing cytology for diagnosis and early d...
Detailed Description
The primary objective of this study is to demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard ERCP with brushing cytology for diagnosis and early detection o...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of PSC
- Clinical indication for ERCP per local standard of practice, such as suspicion of potential malignancy based on worsening cholestatic values or clinical presentation (such as itching, cholangitis) or new biliary stricture on trans-abdominal imaging (MRI/MRCP, US or CT) or suspicious cytology
- Diameter of bile ducts deemed sufficient to accommodate the cholangioscopy system based on imaging performed prior to scheduled ERCP
- Written informed consent from patient to participate in the study, including compliance with study procedures.
Exclusion
- Contraindication for an ERCP or POCS
- History of liver transplantation
- Mass/metastasis extrinsic to the bile duct identifiable on diagnostic imaging
- History of iatrogenic bile duct trauma, including biliary surgery within 6 months of enrollment
- INR \> 1.5 or platelets count \< 50,000
- Age \< 18 years
- Pregnant women or women trying to become pregnant
Key Trial Info
Start Date :
December 6 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 12 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03766035
Start Date
December 6 2018
End Date
December 12 2022
Last Update
January 25 2023
Active Locations (6)
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1
Sutter Davis Hospital
Davis, California, United States, 95616
2
UC Davis Health
Sacramento, California, United States, 95817
3
University of Utah Hospital and Clinic
Salt Lake City, Utah, United States, 84132
4
Aspen Woods Clinic
Calgary, Alberta, Canada, T3H 0V5