Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis

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

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

Treatments tested in this trial

  • EUS-guided transluminal drainage of necrotic collection

Treatment groups

104 Participants
are divided into 2 treatment groups

Sponsors and collaborators