The Value of CT Cholangiography in Primary Sclerosing Cholangitis
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ClinicalTrials.gov Identifier: NCT00588458 |
Recruitment Status
:
Withdrawn
(There is no participant enrolled in this study since developing this trial and other cholangiographic techniques are more available in our institute.)
First Posted
: January 8, 2008
Last Update Posted
: April 28, 2015
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Condition or disease | Intervention/treatment | Phase |
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Primary Sclerosing Cholangitis | Procedure: CT cholangiography | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | Primary Sclerosing Cholangitis: Value of Computerized Tomographic Cholangiography and Intraductal Volumetric Measurement in Determining the Prognosis |
Study Start Date : | March 2007 |
Estimated Primary Completion Date : | November 2008 |
Estimated Study Completion Date : | February 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: single arm
All patients with PSC in will have CT cholangiography.
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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.
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588458
Principal Investigator: | Phunchai Charatcharoenwitthaya, M.D. | Mayo Clinic |
Responsible Party: | Phunchai Charatcharoenwitthaya, M.D., Mayo Clinic and Foundation |
ClinicalTrials.gov Identifier: | NCT00588458 History of Changes |
Other Study ID Numbers: |
06-002976 0 |
First Posted: | January 8, 2008 Key Record Dates |
Last Update Posted: | April 28, 2015 |
Last Verified: | April 2015 |
Keywords provided by Mayo Clinic:
Primary sclerosing cholangitis Computed tomographic cholangiography MELD score Mayo risk score for PSC |
Additional relevant MeSH terms:
Cholangitis Cholangitis, Sclerosing Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |