Multicenter randomized trial comparing short-term stenting versus balloon dilatation for dominant strictures in primary sclerosing cholangitis

Completed

• Conditions: inflammation of the bile ducts; Primary Sclerosing Cholangitis; 10019654

• Registration Number: NL-OMON38315
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

PSC
18-75 years
progression cholestatic complaints
elevated total bilirubin and alkaline phosphatase

Exclusion Criteria

advanced PSC
suppurative cholangitis
malignancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome of the study is the difference in re-intervention free<br /><br>survival time between both groups.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The comparison between both groups of efficacy with regard to the improvement<br /><br>of cholestatic symptoms, biochemical cholestasis, and quality of life.<br /><br>To compare the safety of a single balloon dilatation session with short-term<br /><br>stenting.</p><br>