Actively Recruiting
Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis
Led by Orlando Health, Inc. · Updated on 2026-02-12
104
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Symptomatic necrotic collection diagnosed by MRI or CT, containing necrotic material within a partial or complete wall
- Confirmed or suspected infected necrotizing pancreatitis as defined by positive culture, gas in collection, or clinical/laboratory infection signs
- Endoscopic drainage of the necrotic collection must be technically feasible according to the treating physician
You will not qualify if you...
- Age under 18 years
- More than 26 days since onset of acute pancreatitis
- Need for emergency laparotomy for abdominal catastrophe such as bleeding, bowel perforation, or abdominal compartment syndrome
- Necrotic collection not suitable for endoscopic intervention
- Pregnancy
- Unable to provide informed consent or lack of legally authorized representative to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Orlando Health Digestive Health Institute
Orlando, Florida, United States, 32806
Actively Recruiting
Research Team
J
Ji Young Bang, MD MPH
CONTACT
B
Barbara J Broome
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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