Clinical Trial: Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Multicenter Randomized Trial Comparing Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
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 Summary:
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.
Secondary:
To compare the short term efficacy of single balloon dilatation versus short-term stenting with regard to improvement of cholestatic symptoms, biochemical cholestasis, and quality of life in non-endstage PSC patients at three months; to compare the safety of single balloon dilatation session versus short-term stenting in non advanced PSC patients during two years.
Study design: This is a multicenter, open-label, randomized intervention study.
Study population:
Non-advanced primary sclerosing cholangitis subjects with progression of cholestatic complaints from the outpatient population of the seven participating centres.
Main study parameters/endpoints:
- Difference in re-interventio
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Current Primary Outcome: recurrence-free interval of the primary dominant stricture [ Time Frame: 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: number of patients with adverse events in both groups [ Time Frame: 3 months ]
adverse events within first 3 months after the intervention
Original Secondary Outcome: Same as current
Information By: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dates:
Date Received: April 25, 2011
Date Started: May 2011
Date Completion: May 2015
Last Updated: July 5, 2012
Last Verified: July 2012
