Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis
Necrotizing Pancreatitis
About this trial
This is an interventional treatment trial for Necrotizing Pancreatitis focused on measuring Acute Necrotizing Pancreatitis, Walled-Off Pancreatic Necrosis
Eligibility Criteria
Inclusion Criteria:
- Adult (> 18 yo) patients
- With symptomatic walled- off pancreatic necrosis in which an endoscopic approach is appropriate based on cross-sectional imaging
- Must have solid necrotic material present in their pancreatic fluid collection as determined by MRI, EUS, or direct transluminal endoscopic imaging of the collection
Exclusion Criteria:
- Previous intervention for pancreatic necrosis (surgical, percutaneous, or endoscopic)
- Indication for emergency laparotomy (compartment syndrome, bowel ischemia, bleeding, or perforation of a GI lumen)
- Uncorrectable coagulopathy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Other
Other
Greater than 50% Necrosis
Less than 50% Necrosis
Subjects who have greater than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.
Subjects who have less than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.