Status:
UNKNOWN
Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Primary Sclerosing Cholangitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Primary sclerosing cholangitis (PSC) is a chronic inflammatory disease of the biliary tract of unknown origin. Around 50% of patients develop during their disease course narrowing of the main bile duc...
Detailed Description
Rationale: Primary sclerosing cholangitis is a chronic progressive fibro-obliterative disease of the biliary tree leading to biliary cirrhosis. During its course, dominant strictures occur in approxi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01398917
Start Date
May 1 2011
End Date
May 1 2015
Last Update
July 9 2012
Active Locations (4)
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1
UZLeuven
Leuven, Belgium
2
Academic Medical Center
Amsterdam, Netherlands, 1100 DE
3
Rikshospitalet
Oslo, Norway, N-0027
4
Karolinska Institute
Stockholm, Sweden, 141 86