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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Pancreatic Necrosis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria