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RECRUITING
NCT07406698
NA

Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis

Sponsor: Orlando Health, Inc.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2026-01-28

Completion Date

2029-12-31

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

PROCEDURE

EUS-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