When to do endoscopic drainage for infected necrotizing pancreatitis

Strategic Timing of Endoscopic Procedural Interventions in Infected Necrotizing Pancreatitis: The STEP-IN Trial

We will test if earlier endoscopic drainage (within the first four weeks) helps adults with infected necrotizing pancreatitis recover faster and avoid complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Orlando Health, Inc. (Academic / other)
• Locations: 1 site (Orlando, Florida)
• Trial ID: NCT07406698 on ClinicalTrials.gov

What this trial studies

This interventional study uses endoscopic ultrasound–guided transluminal drainage to manage symptomatic, infected necrotic pancreatic collections. Eligible adults have imaging-confirmed necrosis and documented or suspected infection and may receive earlier endoscopic intervention rather than waiting the traditional four-week walling-off period. Outcomes include infection control, organ failure, need for additional interventions or necrosectomy, complication rates, and length of hospital stay. The goal is to determine whether modern endoscopic approaches performed earlier can safely reduce morbidity and healthcare utilization compared with delayed management.

Who should consider this trial

Good fit: Adults (age ≥18) with symptomatic necrotic pancreatic collections on CT or MRI and documented or strongly suspected infected necrotizing pancreatitis are the ideal candidates.

Not a fit: Patients with small collections likely to resolve without intervention, sterile necrosis, or those with contraindications to endoscopy may not benefit from early drainage.

Why it matters

Potential benefit: If successful, earlier endoscopic drainage could prevent clinical deterioration, reduce complications and hospital stays, and lower the need for more invasive surgery.

How similar studies have performed: Single-center prospective data and recent meta-analyses suggest early endoscopic intervention can be performed safely, but high-quality randomized data remain limited.

Eligibility criteria

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 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:

   1. Temperature \>100.4 °F or \<96.8 °F
   2. Heart rate \> 90 beats/min
   3. Respiratory rate \>20 breaths/min or PaCO2 \< 32 mmHg
   4. WBC count \>12,000/mm³, or \<4,000/mm³, or more than 10% immature band cells
   5. CRP ≥ 30mg/L
   6. Procalcitonin ≥ 1ng/mL
4. Endoscopic drainage of the necrotic collection is technically feasible as deemed by the treating physician.

Exclusion Criteria:

1. Age \< 18 years
2. \> 26 days after the onset of acute pancreatitis
3. Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding, bowel perforation, abdominal compartment syndrome).
4. Necrotic collection is not amenable for endoscopic intervention.
5. Pregnancy.
6. Unable to obtain informed consent from the patient or legally authorized representative.

Where this trial is running

Orlando, Florida

• Orlando Health Digestive Health Institute — Orlando, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Ji Young Bang, MD MPH — Orlando Health
• Study coordinator: Ji Young Bang, MD MPH

Conditions Pancreatitis, Acute Necrotizing; Endoscopic ultrasound; Drainage; Necrotic collection; Timing of intervention