Biodegradable Stents in Primary Sclerosing Cholangitis

Overview

In patients with PSC, endoscopic therapy of strictures aims to improve cholestasis by relieving the biliary obstruction via endoscopic biliary dilatation with consideration of plastic stents in strictures refractory to dilatation due to the risk of pancreatitis and cholangitis . Short term stents have been shown to have similar recurrence-free rates compared to dilatation in a randomised control trial; however, this was terminated after interim analysis due to higher rates of serious adverse events in the stent group. The long term benefits are unclear; however, it may lead to improved survival compared to predicted survival. In this group of patients with limited treatment options, biodegradable stents may provide an attractive additional treatment modality in the management of high grade strictures.

Research hypothesis The use of biodegradable stents leads to remodelling of high grade strictures in patients with PSC with fewer interventions in comparison to balloon dilation alone with a comparable risk profile to current therapy. Primary endpoint Technical success and safety of biodegradable stent placement at ERC Secondary endpoints * Cumulative recurrence -free rate of primary high grade strictures within 12 months * Change in symptoms as assessed by the Amsterdam cholestatic complaints score (ACCS) * Clinical success is defined by improvement in liver function tests (LFT) by 20% at week 2 and week 12. * Improvement in quality fo life as assessed by the Short form-36 (SF-36). * Mortality, morbidity, local complications, stricture recurrence, decompensation of liver disease, liver transplantation over 12 months.