Randomised Trial Comparing Short-term Stenting versus Balloon-dilatation for Dominant Strictures in Primary Sclerosing Cholangitis the DILSTENT2 study.

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Presentation transcript:

Randomised Trial Comparing Short-term Stenting versus Balloon-dilatation for Dominant Strictures in Primary Sclerosing Cholangitis the DILSTENT2 study opportunities within a study group IPSG meeting june 2010 opportunities within a study group IPSG meeting june 2010 C. Ponsioen

treatment of dominant strictures treatment of dominant strictures balloon dilatation Gotthardt et al GIE 2010; 71: 527

treatment of dominant strictures short-term stenting: results Ponsioen et al. Am J Gastroenterol 1999; 94: 2403

Survival curves DILSTENT1 p<0.05 n=12 n=6

current situation DS are a sizeable and relevant problem no proper data on best treatment regarding: relief of symptoms imrpovement of biochemical cholestasis duration of effect of treatment impact on prognosis DS are a sizeable and relevant problem no proper data on best treatment regarding: relief of symptoms imrpovement of biochemical cholestasis duration of effect of treatment impact on prognosis

study proposal: DILSTENT2 multicenter randomized trial comparing short-term stenting vs balloon dilatation for DS in PSC N=100 primary outcome parameter: re-intervention free survival proportion after 2 years secondary outcome parameters: Δ cholestatic symptoms at t=2 mth Δ biochemical cholestasis at t=2 mth Δ SF-36 score at t=2 mth procedure related complications multicenter randomized trial comparing short-term stenting vs balloon dilatation for DS in PSC N=100 primary outcome parameter: re-intervention free survival proportion after 2 years secondary outcome parameters: Δ cholestatic symptoms at t=2 mth Δ biochemical cholestasis at t=2 mth Δ SF-36 score at t=2 mth procedure related complications