Clinical Trial: The Value of CT Cholangiography in Primary Sclerosing Cholangitis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Primary Sclerosing Cholangitis: Value of Computerized Tomographic Cholangiography and Intraductal Volumetric Measurement in Determining the Prognosis

Brief Summary: The reason for this study is to see if a new radiologic technique called computerized tomographic cholangiography (CT cholangiography) could be helpful to demonstrate the bile ducts features and measure the amount of space of bile duct canals that should be filled with bile fluid. It may be useful to find out how well these findings correlate with the previously known clinical predictors in term of the clinical outcomes that will happen in the future for patients with primary sclerosing cholangitis (PSC).

Detailed Summary: Prognostic models, which have been produced based on clinical, histological and biochemical feature, are useful in predicting survival and determining timing for liver transplantation. Preliminary feasibility studies in patients with PSC using high resolution CT with a contrast agent (CT cholangiography), has shown excellent depiction of bile ducts. CT cholangiography also has the potential to allow quantification of intraductal volume by using sophisticated computer programs. This assessment may be an important clinical feature to assess disease severity and progression.The information about cholangiographic features could be important for therapeutic decisions (e.g., in determining the usefulness of balloon dilatation or stenting for a dominant extrahepatic duct stricture), for counseling patients, and for therapeutic trials in stratifying patients and assessing efficacy of treatment.
Sponsor: Mayo Clinic

Current Primary Outcome: To determine the correlation between baseline characteristics of bile ducts and intraductal volume of the biliary tree by CT cholangiography and MELD score and the Mayo risk score in patients with PSC. [ Time Frame: baseline ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To determine the correlation between change in characteristics of bile ducts and intraductal volume of the biliary tree by CT cholangiography and change in MELD score and the Mayo risk score after 2-years of follow-up as compared with baseline. [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: December 26, 2007
Date Started: March 2007
Date Completion: February 2009
Last Updated: April 27, 2015
Last Verified: April 2015