Comparison of FCSEMS and Plastic Stents

Inclusion Criteria

• •1. The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
• •2. The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.
• •3. Males or females ≥ 18 years of age.
• •4. WON diagnosed on contrast-enhanced dual phase CT abdomen/pelvis (CECT) or MRI with gadolinium (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a well-defined tissue layer).
• •5. WON of any size with any quantity of solid/necrotic component and any no. of loculations, located within the pancreatic/peri-pancreatic space not requiring percutaneous drainage, within 2cm of the enteric wall
• •6. Suspected/confirmed infected WON (defined as temp ≥ 100.5°F, serum White Blood Cells ≥ 15x109/L, positive blood cultures or positive Gram stain/culture of aspirated necrotic material), and/or symptomatic WON (defined as abdominal pain, gastric/intestinal/biliary outlet obstruction resulting in nausea, vomiting, early satiety, jaundice, or persistent malaise) ≥ 4 weeks from attack of acute pancreatitis.
• •7. Documented history of acute or chronic pancreatitis:
• •i. Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met:
• •1. Abdominal pain characteristic of acute pancreatitis
• •2. Serum lipase/amylase ≥ x3 upper limit of normal
• •3. Characteristic radiological findings of acute pancreatitis on CECT/MRI/US abdomen, such as homogeneous enhancement of pancreatic parenchyma, standing of peripancreatic fat ii. Chronic pancreatitis is diagnosed if characteristic radiological changes are seen on CT/MRI with Magnetic resonance cholangiopancreatography (MRCP) (such as pancreatic atrophy, dilated pancreatic duct, pancreatic calcification) or EUS (≥5/9 of Rosement criteria)
• •8. Able to undergo general anesthesia