Trial ID or NCT#

NCT01818050

Status

RECRUITING

Purpose

Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for resolution of biliary obstruction has been the method of choice for many years. However, stent clogging/obstruction is a major limitation in the management of biliary obstruction. 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 WS up to 90 days in 50 patients with biliary obstruction due to stones or benign strictures.

Official Title

Prospective Evaluation of Stent Patency in Patients With Benign Biliary Obstruction of the Wing Biliary Stent (Viaduct™)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Subhas Banerjee
Gastroenterologist, Therapeutic endoscopy specialist, Biliary specialist, Endoscopic ultrasound specialist
Professor of Medicine (Gastroenterology and Hepatology) at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

CONTACT

Subhas Banerjee, MD
(650) 723-2623