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

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

Detailed Description
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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.

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

Conditions
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Biliary Stricture

Intervention / Treatment
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* Device: Winged biliary stent (ViaDuct™)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Winged stent<br>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™)<br>* Placement of winged biliary stent at ERCP for management of benign biliary stricture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of Participants With Stent Patency at 90 Days | Evaluation of laboratory studies and clinical status to assess for stent patency/evidence of biliary obstruction | 90 days after placement of stent |