GORE® VIABIL® Biliary Endoprosthesis for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis (VIABILITY)

Inclusion Criteria A diagnosis of chronic pancreatitis Indication for ERCP with FCSEMS placement determined by one or more of the following: Presence of a Bismuth type I BBS confirmed by imaging (e.g., cholangiography, Computed Tomography [CT], Magnetic Resonance Cholangiopancreatography [MRCP], etc.) collected ≤ 60 days prior to the index procedure and an elevation of serum alkaline phosphatase (>2 times the upper limit of institutional reference range) Presence of a symptomatic (e.g., jaundice, cholangitis, and/or choledocholithiasis) Bismuth type I BBS confirmed by imaging (e.g., cholangiography, CT, MRCP, etc.) collected ≤ 60 days prior to the index procedure with an elevation of serum alkaline phosphatase (>2 times the upper limit of institutional reference range) A planned exchange of multiple side-by-side plastic stents (whose combined diameters are ≤ 20 Fr) that were previously placed for management of a Bismuth type I BBS secondary to chronic pancreatitis Underlying stricture malignancy has been reasonably excluded (e.g., by any of the following techniques - biopsy, Endoscopic Ultrasound [EUS], Computed Tomography [CT], or Magnetic Resonance Imaging [MRI] with or without Magnetic Resonance Cholangiopancreatography [MRCP]) ≤ 60 days prior to index procedure ≥ 18 years old at the time of informed consent signature Male, infertile female, or woman of childbearing potential with a negative beta Human Chorionic Gonadotropin (hCG) pregnancy test within 7 days of the index procedure Able and willing to provide written informed consent (or has a Legally Authorized Representative) to participate in the study prior to any study procedures Willing and able to comply with the study procedures and follow-up requirements Exclusion Criteria Concurrent participation in another interventional study that involves an investigational product being introduced to the body A contraindication for endoscopic techniques Life expectancy < 2 years A history of malignant biliary or malignant pancreatic disease Prior or existing biliary self-expanding metal stent (SEMS) Prior or planned exchange of multiple side-by-side plastic stents whose combined diameters are greater than 20 Fr Development of obstructive biliary symptoms associated with a present attack of acute pancreatitis Any biliary stricture etiology other than chronic pancreatitis Other therapeutic endoscopic procedures performed during the index or removal procedure that are not associated with bile duct stricture secondary to Chronic Pancreatitis including but not limited to planned Fine Needle Aspiration (FNA) or Fine Needle Biopsy (FNB) of the pancreas Concomitant Bismuth type II-IV stricture Inability for the guidewire to traverse the papillae and the stricture (e.g., as a result of surgically altered anatomy) Inability to pass the endoscope to the papillae without the need for mechanical dilation Known bile duct fistula or leak Biliary stricture length > 6 cm