WallFlex Biliary Fully Covered (FC) Benign Stricture Study

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

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:

Additional Specific to Liver Transplant Patients:

Primary Outcome Measures

Name	Time	Method
Stent Removability	At stent removal	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.

Secondary Outcome Measures

Name	Time	Method

Locations (13): Westmead Hospital
🇦🇺
Westmead, New South Wales, Australia
Medical University of Vienna
🇦🇹
Vienna, Austria
ULB Erasme Hospital
🇧🇪
Brussels, Belgium
St. Michael's Hospital
🇨🇦
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
🇨🇦
Montreal, Quebec, Canada
MUHC - McGill University
🇨🇦
Montreal, Quebec, Canada
Clinica Alemana de Santiago
🇨🇱
Santiago, Chile
Hopital Edouard Herriot
🇫🇷
Lyon, France
Evangelischen Krankenhaus
🇩🇪
Dusseldorf, Germany
Asian Institute of Gastroenterology
🇮🇳
Hyderabad, India
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Westmead Hospital
🇦🇺Westmead, New South Wales, Australia