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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01398917 |
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Date of registration:
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25/04/2011 |
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Primary sponsor: |
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Public title:
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Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
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Scientific title:
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Multicenter Randomized Trial Comparing Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01398917 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Belgium
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Netherlands
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Norway
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Sweden
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Contacts
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Name:
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Cyriel Y Ponsioen, Dr. |
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Address:
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Telephone:
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+31 20 5666012 |
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Email:
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c.y.ponsioen@amc.nl |
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Affiliation:
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Name:
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Cyriel Y Ponsioen, dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academic Medical Center, Amsterdam, The Netherlands |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- PSC ascertained with MRCP, ERCP, PTC and/or liver biopsy or
- PSC highly suspected and to be confirmed with present ERCP
- Age between 18-75 years
- Total bilirubin > 3x ULN or rsie in alkaline phosphatase or bilirubin > 50% together
with increase in cholestatic complaints
Exclusion Criteria:
- Prior stenting or balloon-dilatation within last 6 months
- Clinical signs serious suppurative cholangitis reflected by either fever > 39.0 °C,
tachycardia, leukocytosis and elevated CRP, or fever > 38,5 C together with purulent
bile found during ERCP.
- Change of ursodeoxycholic acid therapy shorter than two months ago.
- Inability to give written informed consent
- Signs of biliary cirrhosis Child-Pugh B or C
- Estimated transplant-free survival shorter than 2 years as calculated by a Mayo score
< 2
- Serious suspicion of cholangiocarcinoma, reflected by an imaging study suggestive of
metastasis, MRCP with mass lesion with contrast enhancement, rise in CA19.9 of > 63
U/ml with an absolute value > 130 U/ml 14 .
- Signs of current malignancy other than basocellular skin carcinoma.
- Inability to give informed consent.
- Life expectancy < 24 months.
- Use of antibiotics in previous 4 weeks.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Sclerosing Cholangitis
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Intervention(s)
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Procedure: balloon dilatation
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Procedure: plastic endoprosthesis
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Primary Outcome(s)
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recurrence-free interval of the primary dominant stricture
[Time Frame: 24 months]
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Secondary Outcome(s)
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number of patients with adverse events in both groups
[Time Frame: 3 months]
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Secondary ID(s)
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DILSTENT2
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NL34454.018.10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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