Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis
Strategic Timing of Endoscopic Procedural Interventions in Infected Necrotizing Pancreatitis: The STEP-IN Trial
Orlando Health, Inc.
104 participants
Jan 28, 2026
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
Inclusion Criteria10
- Age ≥ 18 years
- Patients with symptomatic necrotic collection diagnosed on MRI or CT abdomen/pelvis, defined as fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a partial or complete wall.
- Documented or suspected infected necrotizing pancreatitis 1) Documented infected necrotizing pancreatitis, defined as: i. Positive culture obtained with percutaneous fine needle aspiration from the pancreatic necrotic collection (if intervention is undertaken ≤14 days of onset of acute pancreatitis) ii. OR gas in the necrotic collection on imaging at any time. 2) Suspected infected necrotizing pancreatitis, if \>14 days after onset of disease, defined as: i. Persistent organ failure in patients admitted to the ICU ii. OR presence of at least three of the following six clinical/laboratory parameters (SIRS criteria or elevated CRP or elevated procalcitonin) with no other infection focus. These clinical criteria are considered sufficiently reliable only after the initial 14 days of acute pancreatitis:
- Temperature \>100.4 °F or \<96.8 °F
- Heart rate \> 90 beats/min
- Respiratory rate \>20 breaths/min or PaCO2 \< 32 mmHg
- WBC count \>12,000/mm³, or \<4,000/mm³, or more than 10% immature band cells
- CRP ≥ 30mg/L
- Procalcitonin ≥ 1ng/mL
- Endoscopic drainage of the necrotic collection is technically feasible as deemed by the treating physician.
Exclusion Criteria6
- Age \< 18 years
- \> 26 days after the onset of acute pancreatitis
- Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding, bowel perforation, abdominal compartment syndrome).
- Necrotic collection is not amenable for endoscopic intervention.
- Pregnancy.
- Unable to obtain informed consent from the patient or legally authorized representative.
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Interventions
EUS-guided drainage of the necrotic collection is performed by placement of a metal stent within the dominant collection.
Locations(1)
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NCT07406698