Biodegradable STents in Primary Sclerosing Cholangitis - BSTPSC
Research type
Research Study
Full title
Pilot Study of Biodegradable STents in Primary Sclerosing Cholangitis - BSTPSC
IRAS ID
336318
Contact name
Deepak Joshi
Contact email
Sponsor organisation
King's College Hospital
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Primary sclerosing cholangitis (PSC) is a long-term health condition involving narrowing of the pipes that drain bile from the liver (bile ducts). This narrowing progresses over time and patients can develop symptoms and complications, such as bile duct infection (cholangitis), bile duct cancer (cholangiocarcinoma) and liver scarring (cirrhosis). A particular concern is when a single major narrowing of the bile duct (high grade biliary strictures) develops, as these are associated with high risk of complications. Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure commonly performed in patients with PSC and high grade biliary strictures for two main reasons. Firstly, to take samples from the bile ducts to investigate if there is evidence of cholangiocarcinoma. Secondly, to improve bile duct drainage and symptoms associated with the high grade biliary strictures. The stricture can be treated at ERCP by inflating a balloon within the bile duct, or in some patients a temporary small plastic tube (stent) can be inserted. Plastic stents are as effective but are a higher risk of infections after the ERCP, in part because they can get coated with germs over time and block before they are removed. Also, a second procedure is required to remove the plastic stent.
A new type of stent is being used at ERCP, which is made of a material which disintegrates over time (biodegradable). This has been shown to be safe and effective in patients needing stents at ERCP, and patients require less procedures than with traditional plastic stents. It has been used in patients having ERCP for other reasons, but has not been evaluated in patients with PSC. We are planning this study to show how safe and effective the biodegradable stent is for patients with PSC and high grade biliary strictures.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
25/WM/0217
Date of REC Opinion
2 Dec 2025
REC opinion
Further Information Favourable Opinion