Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07406698

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

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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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Orlando Health Digestive Health Institute

Orlando, Florida, United States, 32806

Actively Recruiting

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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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