Endoscopic Step-up Approach Vs Aggressive Debridement of Large Pancreatic Walled-off Necrosis

Launched by COPENHAGEN UNIVERSITY HOSPITAL, HVIDOVRE · Oct 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to treat patients with a serious condition called acute necrotizing pancreatitis, which can cause large areas of dead tissue in the pancreas (known as walled-off necrosis). The trial is comparing a standard treatment method, called the endoscopic step-up approach, to a more aggressive treatment method, which involves directly removing the dead tissue. The researchers want to find out if the more aggressive approach can help patients recover faster and reduce the number of deaths related to this condition.

To participate in the trial, patients need to be between the ages of 65 and 74 and have a specific type of walled-off necrosis that is larger than 15 centimeters. They must also show signs that they need this type of treatment, such as severe pain, infection, or blockage in the digestive system. Participants can expect to undergo imaging tests and may receive either of the two treatment methods during the trial. It's important to note that certain people, such as those under 18, pregnant women, or those with specific medical conditions, cannot participate in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All criteria must be fulfilled
• • 1. 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.
• 2. One or more indication(s) for endoscopic, transmural drainage must be established:
• • 1. Confirmed or suspected infection.
• • 2. Severe intraabdominal hypertension or abdominal compartment syndrome.
• • 3. Persisting abdominal pain, early satiety, or general discomfort.
• • 4. Obstruction of the GI or biliary tract.
• • 5. Leakage of pancreatic juice, e.g. pancreatic ascites or pleural effusion.
• • 3. 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:
• • 1. Patients under the age of 18.
• • 2. Pregnancy.
• • 3. Known or suspected malignant disease.
• • 4. Pancreatitis secondary to trauma or surgical intervention.
• • 5. Chronic pancreatitis.
• • 6. Previous surgical or endoscopic drainage or necrosectomy.