Cholangioscopy in Primary Sclerosing Cholangitis (PSC)



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:December 6, 2018
End Date:August 2021
Contact:Danielle Vannan, PhD
Email:Danielle.Vannan@bsci.com
Phone:508-683-4139

Use our guide to learn which trials are right for you!

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).

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
We found this trial at
2
sites
Calgary, Alberta
Principal Investigator: Johannes Eksteen, MD, PhD
?
mi
from
Calgary,
Click here to add this to my saved trials
Salt Lake City, Utah
Principal Investigator: Douglas Adler, MD
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials