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.
Who can participate
Age range18 Years
SexALL
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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 consen…