RecruitingNot ApplicableNCT07406698

Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis

Strategic Timing of Endoscopic Procedural Interventions in Infected Necrotizing Pancreatitis: The STEP-IN Trial


Sponsor

Orlando Health, Inc.

Enrollment

104 participants

Start Date

Jan 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called EUS-guided transluminal drainage of necrotic collection for people with pancreatitis, acute necrotizing. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEUS-guided transluminal drainage of necrotic collection

EUS-guided drainage of the necrotic collection is performed by placement of a metal stent within the dominant collection.


Locations(1)

Orlando Health Digestive Health Institute

Orlando, Florida, United States

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NCT07406698


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