Endoscopic Intervention Timing for Acute Necrotizing Pancreatitis
(STEP-IN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Pancreatic necrosis complicates approximately 20-30% of severe acute pancreatitis cases. While many collections resolve without intervention, persistent symptomatic collections-particularly when infected-are associated with significant morbidity and mortality and frequently require procedural management. Current guidelines recommend delaying intervention until collections are fully walled off, typically around four weeks. However, in clinical practice, many patients deteriorate before this window is reached.
Prospective data from our institution, supported by recent meta-analyses, suggest that early intervention using modern endoscopic techniques can be performed safely, even when undertaken within the first four weeks of disease onset. We believe that, in appropriately selected patients, early endoscopic intervention may prevent clinical deterioration, reduce complications, shorten hospital stay, and decrease overall healthcare utilization compared with a delayed approach.
To formally evaluate this strategy, an international, multicenter randomized trial is being conducted, entitled Strategic Timing of Endoscopic Procedural Interventions in Infected Necrotizing Pancreatitis (STEP-IN Trial).
Who Is on the Research Team?
Ji Young Bang, MD MPH
Principal Investigator
Orlando Health
Are You a Good Fit for This Trial?
Adults over 18 with acute necrotizing pancreatitis and symptomatic necrotic collections, confirmed by MRI or CT. They must have signs of infection like fever, increased heart or respiratory rate, abnormal white blood cell counts, high procalcitonin or CRP levels. Eligible patients should be able to undergo endoscopic drainage as assessed by a physician.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Early Endoscopic Intervention
EUS-guided drainage is undertaken within 72 hours of randomization, earlier than 28 days after the onset of acute pancreatitis
Postponed Endoscopic Intervention
EUS-guided drainage is undertaken only from 28 days after the onset of acute pancreatitis when the collection is fully or predominantly walled-off
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EUS-guided transluminal drainage of necrotic collection
Trial Overview
The trial is testing the timing of an endoscopic procedure for draining infected pancreatic tissue in severe pancreatitis cases. It compares early intervention within four weeks to the standard delayed approach to see if it prevents worsening conditions, reduces complications and healthcare costs.
How Is the Trial Designed?
2
Treatment groups
Active Control
In the early treatment group, EUS-guided drainage is undertaken within 72 hours of randomization, earlier than 28 days after the onset of acute pancreatitis.
In the postponed treatment group, EUS-guided drainage is undertaken only from 28 days after the onset of acute pancreatitis when the collection is fully or predominantly walled-off (encapsulated).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Orlando Health, Inc.
Lead Sponsor
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