Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
Multicenter Randomized Trial Comparing Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
2 other identifiers
interventional
100
4 countries
4
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 duct with corresponding increase in symptoms such as itching, jaundice and abdominal pain. These narrowings can be treated by balloon dilatation or temporary insertion of a plastic endoprosthesis. However, it is not known which of these two therapeutic modalities is best. This study aims to compare both techniques in order to determine which is best in terms of postponing recurrence of the narrowing, safety and costs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2011
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJuly 9, 2012
July 1, 2012
4 years
April 25, 2011
July 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recurrence-free interval of the primary dominant stricture
24 months
Secondary Outcomes (1)
number of patients with adverse events in both groups
3 months
Study Arms (2)
short-term stenting
ACTIVE COMPARATORone 10 Fr Plastic endoprosthesis or 2 7 Fr plastic endoprosthesis inserted through dominant stricture(s), to be extracted after 1-2 weeks
balloon dilatation
ACTIVE COMPARATOR4 cm 6 mm biliary dilatation balloon to be inflated for 2 minutes in dominant stricture(s)
Interventions
one 10 Fr Plastic endoprosthesis or 2 7 Fr plastic endoprosthesis inserted through dominant stricture(s), to be extracted after 1-2 weeks
4 cm 6 mm biliary dilatation balloon to be inflated for 2 minutes in dominant stricture(s)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
UZLeuven
Leuven, Belgium
Academic Medical Center
Amsterdam, 1100 DE, Netherlands
Rikshospitalet
Oslo, N-0027, Norway
Karolinska Institute
Stockholm, 141 86, Sweden
Related Publications (1)
Ponsioen CY, Arnelo U, Bergquist A, Rauws EA, Paulsen V, Cantu P, Parzanese I, De Vries EM, van Munster KN, Said K, Chazouilleres O, Desaint B, Kemgang A, Farkkila M, Van der Merwe S, Van Steenbergen W, Marschall HU, Stotzer PO, Thorburn D, Pereira SP, Aabakken L. No Superiority of Stents vs Balloon Dilatation for Dominant Strictures in Patients With Primary Sclerosing Cholangitis. Gastroenterology. 2018 Sep;155(3):752-759.e5. doi: 10.1053/j.gastro.2018.05.034. Epub 2018 May 24.
PMID: 29803836DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cyriel Y Ponsioen, dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 25, 2011
First Posted
July 21, 2011
Study Start
May 1, 2011
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
July 9, 2012
Record last verified: 2012-07