The Value of CT Cholangiography in Primary Sclerosing Cholangitis - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588458

Purpose

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).

Condition	Intervention	Phase
Primary Sclerosing Cholangitis	Procedure: CT cholangiography	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment
Official Title:	Primary Sclerosing Cholangitis: Value of Computerized Tomographic Cholangiography and Intraductal Volumetric Measurement in Determining the Prognosis

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
single arm: Experimental All patients with PSC in will have CT cholangiography.	Procedure: CT cholangiography Cholografin 20ml will be diluted in 100 ml of normal saline and infused over 30 minute time interval. Following the infusion of the cholografin, morphine (0.04 mg/kg) will be administered to contract the sphincter of Oddi and improve bile duct distension and visualization. Thirty minutes following the administration of morphine a test scan (CT cholangiography) will be performed through the liver to determine if there is adequate biliary excretion. The test scan will consist of 10 mm thick image obtained through the mid liver. If there is evidence of biliary excretion, high-resolution images will be performed through the liver and bile ducts. The axial images will be reconstructed into maximum intensity projection models and volume rendered models that can be viewed in 3-dimension.

Arms

Assigned Interventions

single arm: Experimental

All patients with PSC in will have CT cholangiography.

Procedure: CT cholangiography

Cholografin 20ml will be diluted in 100 ml of normal saline and infused over 30 minute time interval. Following the infusion of the cholografin, morphine (0.04 mg/kg) will be administered to contract the sphincter of Oddi and improve bile duct distension and visualization. Thirty minutes following the administration of morphine a test scan (CT cholangiography) will be performed through the liver to determine if there is adequate biliary excretion. The test scan will consist of 10 mm thick image obtained through the mid liver. If there is evidence of biliary excretion, high-resolution images will be performed through the liver and bile ducts. The axial images will be reconstructed into maximum intensity projection models and volume rendered models that can be viewed in 3-dimension.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult males or females, age 18-70 (inclusive) with suspected PSC.
Serum carbohydrate antigen 19-9 (CA19-9) level in normal range (obtained within the previous year), or if greater than normal, the patient requires a negative cytologic or histologic evidence for cholangiocarcinoma within prior 3 months.
Sexually active female patients of childbearing potential must be evaluated for pregnancy. A pregnancy test obtained at entry prior to the initiation of treatment must by negative. Female patient must not be breast-feeding.
Renal function: a creatinine less than 2.0 mg/dL or a diabetic patient with a creatinine less than 1.5 mg/dL.

Exclusion Criteria:

Evidence of cholangiocarcinoma
Pregnancy or breast feeding
History of allergy to iodinated contrast agents or morphine
Renal impairment as defined as known renal disease, a creatinine higher than 2.0 mg/dL or a diabetic patient with a creatinine higher than 1.5 mg/dL.
Any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study such as significant cardiovascular dysfunction or chronic obstructive pulmonary disease requiring specific therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588458

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Phunchai Charatcharoenwitthaya, M.D.

Mayo Clinic

More Information

No publications provided

Responsible Party:	Mayo Clinic and Foundation ( Phunchai Charatcharoenwitthaya, M.D. )
Study ID Numbers:	06-002976 0
Study First Received:	December 26, 2007
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00588458 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

Primary sclerosing cholangitis
Computed tomographic cholangiography
MELD score
Mayo risk score for PSC

Study placed in the following topic categories:

Morphine
Cholangitis
Digestive System Diseases
Cholangitis, Sclerosing

Bile Duct Diseases
Biliary Tract Diseases
Primary Sclerosing Cholangitis

Additional relevant MeSH terms:

Cholangitis
Digestive System Diseases
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on May 07, 2009