Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis

NCT07406698 | Recruiting DMC

• 1 other identifier: 2401309
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pancreatitis, Acute Necrotizing

Keywords

Endoscopic ultrasound; Drainage; Necrotic collection; Timing of intervention

Outcome Measures

Primary Outcomes (1)

• Composite of major complications or death

  Proportion of patients experiencing a major complication or death. Major complications comprise new onset organ failure, new onset systemic dysfunction, enteral or pancreatic-cutaneous fistula, intraabdominal bleeding, or visceral perforation.

  6 months

Secondary Outcomes (23)

• Mortality

  6 months

• Major complications

  6 months

• New onset single and multiple organ failure

  6 months

• New onset systemic dysfunction

  6 months

• Enterocutaneous and pancreatic fistula

  6 months

Study Arms (2)

Early endoscopic intervention in infected necrotizing pancreatitis

ACTIVE COMPARATOR

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.

Procedure: EUS-guided transluminal drainage of necrotic collection

Postponed endoscopic intervention in infected necrotizing pancreatitis

ACTIVE COMPARATOR

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).

Procedure: EUS-guided transluminal drainage of necrotic collection

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.

Early endoscopic intervention in infected necrotizing pancreatitis; Postponed endoscopic intervention in infected necrotizing pancreatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orlando Health, Inc.: lead

Study Sites (1)

Orlando Health Digestive Health Institute

Orlando, Florida, 32806, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Ji Young Bang, MD MPH

  Orlando Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Young Bang, MD MPH

CONTACT

321-842-2273; jiyoung.bang@orlandohealth.com

Barbara J Broome

CONTACT

321-841-3742; Barbara.Broome@orlandohealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 12, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)