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Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis

ConditionPancreatitis, Acute Necrotizing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOrlando Health, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Temperature >100.4 °F or <96.8 °F

Heart rate > 90 beats/min

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EUS-guided transluminal drainage of necrotic collection

    Procedure/Surgery

    EUS-guided drainage of the necrotic collection is performed by placement of a metal stent within the dominant collection.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Early endoscopic intervention in infected necrotizing pancreatitisActive comparator 1 intervention
Group B: Postponed endoscopic intervention in infected necrotizing pancreatitisActive comparator 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

Mortality

Proportion of patients with mortality from any cause

Time frame
6 months
2

Major complications

Proportion of patients experiencing major complications. Major complications comprise new onset organ failure (respiratory, cardiovascular, renal, gastrointestinal, hepatic, hematologic, neurologic, or metabolic failure), new onset systemic dysfunction, enteral or pancreatic-cutaneous fistula, intraabdominal bleeding, or visceral perforation

Time frame
6 months
3

New onset single and multiple organ failure

Proportion of patients with new onset failure of at least one organ system

Time frame
6 months
4

New onset systemic dysfunction

Proportion of patients with worsening of any pre-existing medical condition

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Orlando Health, Inc.

Lead sponsor

Source ClinicalTrials.gov
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