DILSTENT-2:
Research type
Research Study
Full title
Multicenter randomized trial comparing short-term stenting versus balloon dilatation for dominant strictures in primary sclerosing cholangitis
IRAS ID
81668
Contact name
Stephen Pereira
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Research summary
Primary sclerosing cholangitis (PSC) is a rare chronic inflammatory disease of the biliary tree surrounded with many obscurities. Its pathogenesis is largely unravelled and its aetiology unknown. Dominant strictures (DS) will occur in approximately 50% of patients. These can be accompanied by lead worsening of symptoms and jaundice and are an indication for endoscopic treatment. Therapy however is limited and treatment often involves dilatation of dominant strictures and in cases of terminal liver failure, orthotopic liver transplantation (OLT) is carried out. Dilation of the DS is done by either balloon dilatation or short-term stent placement, but the best form of treatment has never been investigated. This study will therefore compare the efficacy of short-term stenting versus single session balloon dilatation for dominant strictures in PSC and it will also assess and compare safety of short-term stenting versus balloon dilatation for the treatment of dominant strictures in PSC. The study will be a multicenter prospective open-label randomized intervention trial, recruiting non-advanced PSC patients from the outpatient clinics of five of the participating centres. Patients will either be randomized to placement of stent or balloon dilatation during ERCP with a 2 year follow-up clinic visits every 3 months.
REC name
London - Chelsea Research Ethics Committee
REC reference
13/LO/0433
Date of REC Opinion
9 Oct 2013
REC opinion
Further Information Favourable Opinion