Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis

Conditions

• Pancreatitis, Acute Necrotizing

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date

Jan 28, 2026

Status verified

Jan 2026

Primary completion

Jun 30, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

104 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Early endoscopic intervention in infected necrotizing pancreatitis
  In the early treatment group, EUS-guided drainage is undertaken within 72 hours of randomization, earlier than 28 days after the onset of acute pancreatitis.
• Active Comparator: Postponed endoscopic intervention in infected necrotizing pancreatitis
  In the postponed treatment group, EUS-guided drainage is undertaken only from 28 days after the onset of acute pancreatitis when the collection is fully or predominantly walled-off (encapsulated).

Primary Outcome Measure

Composite of major complications or death [ Time Frame: 6 months ]

Central Contacts

• Ji Young Bang, MD MPH
  321-842-2273
  [email protected]
• Barbara J Broome
  321-841-3742
  [email protected]

Locations (1)

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