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NCT05601687
Endoscopic Step-up Approach vs Aggressive Debridement of Large Pancreatic Walled-off Necrosis
Conditions: Pancreatic Necrosis, Pancreatitis, Acute Necrotizing
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 48
Sponsor: Copenhagen University Hospital, Hvidovre
Location: Denmark
Summary
The goal of this clinical trial is to compare a conventional endoscopic step-up approach with an accelerated treatment algorithm using direct endoscopic necrosectomy in patients with acute necrotizing pancreatitis and walled of necroses exceeding a diameter of 15 cm.
It will be investigated whether an aggressive treatment algorithm instead of a classical step-up approach will shorten the length of stay in the hospital and also reduce the mortality in patients treated for large walled off necroses.
Eligibility Criteria
Inclusion Criteria:All criteria must be fulfilledPatients with acute, necrotizing pancreatitis andWON 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.
Source: ClinicalTrials.gov (NCT05601687). StuddyBuddy aggregates publicly available trial information.