GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis

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

Exclusion criteria