Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

Completed

Conditions studied: Primary Sclerosing Cholangitis (PSC)

In brief

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

Key facts

Study ID

NCT03766035

Run by

Boston Scientific Corporation

People needed

43

Starts

2018-12-06

Expected to finish

2022-12-12

Last updated by the study team

2023-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Sutter Davis Hospital — Davis, California, United States
• UC Davis Health — Sacramento, California, United States
• University of Utah Hospital and Clinic — Salt Lake City, Utah, United States
• Aspen Woods Clinic — Calgary, Alberta, Canada
• Academic Medical Center — Amsterdam-Zuidoost, Netherlands
• Rikshospitalet University Hospital — Oslo, Norway

Full record on ClinicalTrials.gov

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