Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

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 of cholangiocarcinoma in patients diagnosed with primary sclerosing
cholangitis (PSC).

Inclusion Criteria:

1. Confirmed diagnosis of PSC

2. 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

3. Diameter of bile ducts deemed sufficient to accommodate the cholangioscopy system
based on baseline imaging performed within 3 months prior to scheduled ERCP

4. Written informed consent from patient to participate in the study, including
compliance with study procedures.

Exclusion Criteria:

1. Contraindication for an ERCP or POCS

2. History of liver transplantation

3. Mass/metastasis extrinsic to the bile duct identifiable on diagnostic imaging

4. History of iatrogenic bile duct trauma, including biliary surgery within 6 months of
enrollment

5. INR > 1.5 or platelets count < 50,000

6. Age < 18 years

7. Pregnant women or women trying to become pregnant