NCT03115411

Prospective Evaluation of Winged Biliary Stent Patency in Patients With Benign Biliary Obstruction

Prospective Evaluation of Wing Biliary Stent Patency in Patients With Benign Biliary Obstruction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of ERCP with placement of a winged plastic biliary stent without a lumen for management of benign biliary strictures.

Detailed description

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.

Conditions

• Biliary Stricture

Interventions

Type	Name	Description
DEVICE	Winged biliary stent (ViaDuct™)	Placement of winged biliary stent at ERCP for management of benign biliary stricture.

Timeline

• Start date: 2011-09-06
• Primary completion: 2018-04-10
• Completion: 2018-04-10
• First posted: 2017-04-14
• Last updated: 2019-04-16
• Results posted: 2019-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study