Primary Sclerosing CholangitisPhase 2NCT00588458
The Value of CT Cholangiography in Primary Sclerosing Cholangitis
A Phase 2 study testing CT cholangiography in people with Primary Sclerosing Cholangitis, run by Mayo Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- CT cholangiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Primary Sclerosing Cholangitis: Value of Computerized Tomographic Cholangiography and Intraductal Volumetric Measurement in Determining the Prognosis
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).
Read the 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.
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- CT cholangiography
- Keywords
- Primary sclerosing cholangitis, Computed tomographic cholangiography, MELD score, Mayo risk score for PSC
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT cholangiographyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | All patients with PSC in will have CT cholangiography. Receives: Procedure: CT cholangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startMar 2007
- Primary completionNov 2008 (estimated)
- Study completionFeb 2009 (estimated)
Why it stopped: There is no participant enrolled in this study since developing this trial and other cholangiographic techniques are more available in our institute.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Phunchai Charatcharoenwitthaya, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588458
- Sponsor's protocol ID
- 06-002976 0
- Status last verified
- Apr 2015
- First submitted
- 26 Dec 2007
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Sclerosing Cholangitis: Value of Computerized Tomographic Cholangiography and Intraductal Volumetric Measurement in Determining the Prognosis
- ClinicalTrials.gov ID
- NCT00588458
- Acronym / sponsor ID
- 06-002976 0
- Conditions
- Primary Sclerosing Cholangitis
- Keywords
- Primary sclerosing cholangitis, Computed tomographic cholangiography, MELD score, Mayo risk score for PSC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There is no participant enrolled in this study since developing this trial and other cholangiographic techniques are more available in our institute.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 8 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Procedure: CT cholangiographyAll patients with PSC in will have CT cholangiography. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT cholangiographyCholografin 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. | Procedure or surgery | single arm |
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
1 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phunchai Charatcharoenwitthaya, M.D. principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT cholangiography in people with Primary Sclerosing Cholangitis, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.