Strategic Timing of Endoscopic Procedural Interventions in Infected Necrotizing Pancreatitis: The STEP-IN Trial
Orlando Health, Inc.
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).
Description
Acute pancreatitis imposes a significant burden on the US health-care system, resulting in approximately 300,000 hospital admissions annually and generating costs exceeding $2 billion. Necrotizing pancreatitis develops in approximately 20 to 30% of patients with acute pancreatitis. It can mature into a contained necrotic collection, typically four weeks into the disease course. While some collections may resolve without an intervention, persistent collections can result in symptoms such as pain, abdominal fullness restricting nutrition, vomiting due to gastric outlet obstruction, obstructive j…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years 2. 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. 3. 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…
Interventions
- ProcedureEUS-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.
Location
- Orlando Health Digestive Health InstituteOrlando, Florida