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

Status unconfirmed · Phase 4

Conditions studied: Bile Duct Stricture

In brief

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.

Key facts

Study ID

NCT01818050

Run by

Stanford University

People needed

50

Starts

2013-03-01

Expected to finish

2014-03-01

Last updated by the study team

2013-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients age 18 or older referred for ERCP for biliary obstruction from stones or benign strictures that have been confirmed based on clinical, laboratory and imaging findings, with an indication for plastic stent placement.
• One or more biliary stents may be placed during the procedure depending on the indication such as a biliary stricture necessitating multiple stent placements for dilation as the standard of care.
• Expected patient survival of at least 90 days
• High likelihood of patient follow-up
• Patient is able to give a written informed consent
• Patient is willing and able to comply with the study procedures.

You may not qualify if…

• Patients with cholangitis
• Patients with bile leak
• Pregnant patients
• Patients with any contraindication to endoscopic procedure
• Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
• Patients with malignant biliary strictures

Where it is running

• Stanford University Hospital — Palo Alto, California, United States (enrolling)

Full record on ClinicalTrials.gov

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