Multicenter Randomized Trial Comparing Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 100
- Locations
- 7
- Primary Endpoint
- recurrence-free interval of the primary dominant stricture
Study Overview
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.
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 approximately 50% of patients. These can be accompanied by lead worsening of symptoms and jaundice and are an indication for endoscopic treatment. The best form of treatment, either balloon dilatation or short-term stent placement, has never been formally investigated.
Objective:
Primary:
To compare the efficacy of single session balloon dilatation versus short-term stent placement in non-advanced PSC patients with regard to re-intervention free recurrence rate at two years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
recurrence-free interval of the primary dominant stricture
Time Frame: 24 months
Secondary Outcomes
- number of patients with adverse events in both groups(3 months)
Investigators
C.Y. Ponsioen
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)