The Value of CT Cholangiography in Primary Sclerosing Cholangitis

NCT00588458 | Withdrawn Phase 2 DMC

• 1 other identifier: 06-002976 0
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Primary Sclerosing Cholangitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline

Secondary Outcomes (1)

• 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.

  2 years

Study Arms (1)

single arm

EXPERIMENTAL

All patients with PSC in will have CT cholangiography.

Procedure: CT cholangiography

Interventions

CT cholangiography PROCEDURE

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.

single arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Phunchai Charatcharoenwitthaya, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 8, 2008
• Study Start: March 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: February 1, 2009
• Last Updated: April 28, 2015

Record last verified: 2015-04