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Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis

NCT07406698 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-02-12

No results posted yet for this study

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).

Conditions

  • Pancreatitis, Acute Necrotizing

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.

Sponsors & Collaborators

  • Orlando Health, Inc.

    lead OTHER

Principal Investigators

  • Ji Young Bang, MD MPH · Orlando Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-28
Primary Completion
2029-06-30
Completion
2029-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07406698 on ClinicalTrials.gov