WallFlex Biliary Fully Covered (FC) Benign Stricture Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.

Official Title
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A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures

Conditions
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Biliary Stricture

Intervention / Treatment
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* Device: WallFlex Biliary RX Fully Covered Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Willing and able to comply with the study procedures and provide written informed consent to participate in the study Chronic pancreatitis or prior liver transplantation or prior other abdominal surgery (to include cholecystectomy) Indicated for ERCP procedure with stent placement for: Symptomatic bile duct stricture (i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed by cholangiogram and/or Bile duct stricture confirmed by cholangiogram and/or Exchange of prior plastic stent(s) for management of benign stricture Exclusion Criteria: General: Placement of the stent in strictures that cannot be dilated enough to pass the delivery system Placement of the stent in a perforated duct Placement of the stent in very small intrahepatic ducts Patients for whom endoscopic techniques are contraindicated Biliary stricture of malignant etiology Biliary stricture of benign etiology other than chronic pancreatitis or liver transplant anastomosis or other abdominal surgery Stricture within 2 cm of duct bifurcation Symptomatic duodenal stenosis (with gastric stasis) Prior biliary self-expanding metal stent Suspected stricture ischemia based on imaging of hepatic artery occlusion or endoscopic evidence of biliary cast syndrome Known bile duct fistula Known sensitivity to any components of the stent or delivery system Participation in another investigational study within 90 days prior to consent or during the study Additional Specific to Chronic Pancreatitis Patients: Developing obstructive biliary symptoms associated with an attack of acute pancreatitis Additional Specific to Post-Abdominal Surgery Patients: History of hepatectomy History of liver transplant Additional Specific to Liver Transplant Patients: Live donor transplantation

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WallFlex Biliary RX FC Stent System<br>The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures. | Device: WallFlex Biliary RX Fully Covered Stent System<br>* Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Removability | Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal. | At stent removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benign biliary strictures secondary to chronic pancreatitis/post abdominal surgery/post liver transplant