Covered metallic stents for benign bile duct strictures
Research type
Research Study
Full title
Use of fully-covered, self-expandable metallic stents for first-line treatment of benign bile duct strictures
IRAS ID
145306
Contact name
SHYAM MENON
Contact email
Sponsor organisation
The Royal Wolverhampton NHS Trust
Clinicaltrials.gov Identifier
Research summary
Benign bile duct strictures refer to a non-cancerous narrowing in the bile duct that can arise as a complication following a cholecystectomy (gall-bladder operation), following surgery on the bile duct, following a liver transplant and in relation to inflammation of the bile duct secondary to conditions such as primary sclerosing cholangitis (PSC), chronic pancreatitis and other cholangiopathies (inflammatory diseases of the bile duct).
A stricture (narrowing) in the bile duct can result in impairment of flow of bile from the liver which may cause jaundice, itching and impairment of fat digestion over the short term and the development of permanent liver damage (secondary biliary cirrhosis) in the longer term.
Traditionally, strictures in the bile duct have been treated through complex surgery with associated risks. However, following advances in endoscopic technology, such strictures are now commonly treated during endoscopy through the insertion of ‘stents’, which are hollow, cylindrical, flexible devices that can be inserted into a narrow segment of bile duct to relieve obstruction. The endoscopic procedure involves the insertion of a video telescope through the mouth and into the bowel under sedation.
Until recently, stents were made from plastic compounds and patients needed repeated endoscopic procedures to insert multiple plastic stents into the stricture in order to gradually stretch it open over a period of several months. Covered ‘metallic’ stents are new, removable stents made out of flexible metal alloys and are increasingly favoured to treat strictures due to their greater inner diameter that ensures a more efficient dilatation (stretch) of the stricture. These stents can be left in place for many months, thereby limiting the number of endoscopic sessions.
There has been no direct comparative study between the use of plastic and metallic stents in treating benign bile duct strictures and the present study seeks to examine this question.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
14/WM/0089
Date of REC Opinion
20 Mar 2014
REC opinion
Favourable Opinion