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