Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy for PSC Biliary Strictures

Completed

Conditions studied: Primary Sclerosing Cholangitis

In brief

Primary sclerosing cholangitis (PSC) 1. Prospectively validate interpretation criteria for the characterization of PSC strictures 2. Prospectively evaluate the accuracy of pCLE for the characterization of PSC strictures (differentiation between malignant vs. non malignant strictures), using the newly developed interpretation criteria 3. Evaluate the feasibility and safety of pCLE for the characterization of PSC strictures

Key facts

Study ID

NCT02736708

Run by

University of Colorado, Denver

People needed

65

Starts

2013-01-01

Expected to finish

2020-05-01

Last updated by the study team

2020-08-26

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female > 18 years of age
• Clinically Indicated for ERCP and/or cholangioscopy for PSC stricture
• Inclusion of patients either previously stented or not

You may not qualify if…

• Subjects for whom ERCP procedures are contraindicated
• Known allergy to fluorescein dye
• Presence of well-defined intrahepatic mass
• Ascending cholangitis, febrile at time of procedure
• Pregnancy

Where it is running

• University of Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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