Prospective Evaluation of Winged Biliary Stent Patency in Patients With Benign Biliary Obstruction
|ClinicalTrials.gov Identifier: NCT03115411|
Recruitment Status : Completed
First Posted : April 14, 2017
Results First Posted : April 4, 2019
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Biliary Stricture||Device: Winged biliary stent (ViaDuct™)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients with benign biliary obstruction who meet all inclusion criteria will be approached to consent for placement of a winged biliary stent for 90 days with appropriate laboratory studies and clinical evaluations.|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of Wing Biliary Stent Patency in Patients With Benign Biliary Obstruction|
|Actual Study Start Date :||September 6, 2011|
|Actual Primary Completion Date :||April 10, 2018|
|Actual Study Completion Date :||April 10, 2018|
Experimental: Winged stent
Placement of Winged stent for management of biliary obstruction. Stent to be placed for 90 days, with laboratory studies and clinical evaluation during this period to assess for stent potency.
Device: Winged biliary stent (ViaDuct™)
Placement of winged biliary stent at ERCP for management of benign biliary stricture.
- Count of Participants With Stent Patency at 90 Days [ Time Frame: 90 days after placement of stent ]Evaluation of laboratory studies and clinical status to assess for stent patency/evidence of biliary obstruction
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115411
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|