Recruiting

Endoscopic Intervention

Sponsor:

Orlando Health, Inc.

Code:

NCT07406698

Conditions

Pancreatitis, Acute Necrotizing

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EUS-guided transluminal drainage of necrotic collection

Study Details

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

Study ID

NCT07406698

Start date

Jan 28, 2026

Status verified date

Jan, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

EUS-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.

Primary outcome measure

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

Central Contacts and Locations

Locations

Orlando Health Digestive Health Institute

Recruiting

Orlando, Florida, United States, 32806

Contacts

More Information

Sponsor

Orlando Health, Inc.

Last update posted

Feb 12, 2026

Last verified

Jan, 2026

Keywords

  • Endoscopic ultrasound
  • Drainage
  • Necrotic collection
  • Timing of intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Orlando Health, Inc. on 2026-02-12.