WallFlex Biliary Fully Covered (FC) Benign Stricture Study
- Conditions
- Biliary Stricture
- Interventions
- Device: WallFlex Biliary RX Fully Covered Stent System
- Registration Number
- NCT01014390
- Lead Sponsor
- Boston Scientific Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 187
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description WallFlex Biliary RX FC Stent System WallFlex Biliary RX Fully Covered Stent System The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.
- 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
Trial Locations
- Locations (13)
Clinica Alemana de Santiago
🇨🇱Santiago, Chile
Asian Institute of Gastroenterology
🇮🇳Hyderabad, India
MUHC - McGill University
🇨🇦Montreal, Quebec, Canada
Medical University of Vienna
🇦🇹Vienna, Austria
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
ULB Erasme Hospital
🇧🇪Brussels, Belgium
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Hopital Edouard Herriot
🇫🇷Lyon, France
Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
🇨🇦Montreal, Quebec, Canada
Evangelischen Krankenhaus
🇩🇪Dusseldorf, Germany
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
🇮🇹Rome, Italy
Hospital Universitari Doctor Josep Trueta
🇪🇸Girona, Catalunya, Spain
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands