Biliary Stricture Clinical Trial
Official title:
Prospective Evaluation of Wing Biliary Stent Patency in Patients With Benign Biliary Obstruction
Evaluation of ERCP with placement of a winged plastic biliary stent without a lumen for management of benign biliary strictures.
ERCP with plastic stent placement for resolution of biliary obstruction has been the method
of choice for many years. However, stent obstruction is a major limitation of this approach.
Studies have shown that the conventional tubular type polyethylene stents (CS) with side
holes accumulate significant sludge and their mean patency is approximately 90 days.
Thus patients requiring longer term stenting need to undergo stent exchanges every 2-3
months.
Recently, a stent with a star-shaped cross-section has been developed for biliary
applications. This FDA approved biliary Wing stent (WS) (ViaDuct™) is a novel plastic biliary
stent that lacks a lumen, and is designed to allow bile to flow on the outside of the stent.
The stent which is star shaped in cross section, channels fluid along its winged perimeter.
It has been proposed that the winged stent design with a lack of central lumen obviates the
risk of luminal occlusion and that the risk of occlusion, given the presence of multiple
external drainage channels, is smaller. Longer term biliary drainage without the need for
stent exchange should therefore be possible with these stents.
The primary aim of this study is to prospectively evaluate the patency rate of the winged
stent in up to 90 days for patients with benign biliary obstruction.
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