Endoscopic Step-up Approach vs Aggressive Debridement of Large Pancreatic Walled-off Necrosis
Pancreatic Necrosis, Pancreatitis, Acute Necrotizing
About this trial
This is an interventional treatment trial for Pancreatic Necrosis focused on measuring Walled-off necrosis, Walled-off pancreatic necrosis, Endoscopic necrosectomy, Video-assisted retroperitoneal debridement
Eligibility Criteria
Inclusion Criteria: All criteria must be fulfilled Patients with acute, necrotizing pancreatitis and WON exceeding a diameter of 15 cm. Imaging test(s) must be done within 1 week before the index drainage procedure. Debut of pancreatitis must be within 3 months before the index drainage procedure. One or more indication(s) for endoscopic, transmural drainage must be established: Confirmed or suspected infection. Severe intraabdominal hypertension or abdominal compartment syndrome. Persisting abdominal pain, early satiety, or general discomfort. Obstruction of the GI or biliary tract. Leakage of pancreatic juice, e.g. pancreatic ascites or pleural effusion. Preoperatively, the WON must be considered eligible for endoscopic, transgastric drainage. Distance between the gastric wall and WON must not exceed one cm and there must be no major interposed vessels. Exclusion Criteria: Patients under the age of 18. Pregnancy. Known or suspected malignant disease. Pancreatitis secondary to trauma or surgical intervention. Chronic pancreatitis. Previous surgical or endoscopic drainage or necrosectomy.
Sites / Locations
- Copenhagen University Hospital, HvidovreRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Step-up Approach
Direct Endoscopic Necrosectomy
Standard procedure where necrosectomy is only performed in the absence of clinical improvement 72 hours after placements of lumen-apposing metal stent.
Necrosectomy will be performed in the same procedure as the placement of the lumen-apposing metal stent.