CompletedNot Applicable

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

Denmark25 participantsStarted 2022-11-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with acute, necrotizing pancreatitis and
✓. 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.

What they're measuring

A composite of major complications, death, or length of stay exceeding 58 days

Timeframe: From date of randomization until discharge, assessed up to 12 months

Trial details

NCT IDNCT05601687

SponsorCopenhagen University Hospital, Hvidovre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-15

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