DEciphering CIrculating SIgnatures Of Infected Pancreatic Necrosis

The purpose of the study is to identify novel blood-based biomarkers for prediction and diagnosis of infected pancreatic necrosis (IPN) in patients with necrotizing pancreatitis (NP).

Acute pancreatitis (AP) is the leading cause of gastrointestinal hospital admissions, accounting for over 300,000 emergency department visits annually and imposing a significant socio-economic burden. It is an acute inflammatory condition of the pancreas characterized by damage to the acinar cells, which triggers an inflammatory response and causes widespread systemic damage. In about 20% of cases, the disease progresses to necrotizing pancreatitis (NP), a severe form characterized by tissue necrosis. NP poses serious health risks, especially when the necrotic tissue becomes infected, leading to infected (peri-)pancreatic necrosis (IPN), which is associated with secondary organ failure (OF), sepsis, and mortality rates as high as 40%. While patients with sterile (peri-)pancreatic necrosis (SPN) can often be managed conservatively, those with IPN typically require antibiotics and therapeutic interventions such as endoscopic drainage or surgery.

Timely recognition and treatment of IPN are crucial for improving patient outcomes, yet current diagnostic methods based on clinical symptoms and routine lab markers lack the specificity to reliably distinguish SPN from IPN in the early stages. Furthermore, while multifactorial scoring systems like Ranson, Imrie, and APACHE II predict necrosis and overall severity in AP, they are not accurate for identifying IPN or predicting mortality in NP. The diagnostic gap delays appropriate treatment, allowing the infection to advance and limiting available therapeutic options. The growing incidence and significant impact of AP and NP in the general population underscore the urgent need to better understand IPN pathophysiology and to develop specific diagnostic biomarkers that can improve prognosis, guide therapeutic decisions, and enhance patient outcomes.

Study Overview

• Status: Recruiting
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Other: not interventional

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Petr Vanek, MD, PhD; Email: pvanek@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Petr Vanek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult (>18 years) patients with a diagnosis of NP based on contrast-enhanced computed tomography (CECT) after 2 weeks from AP onset at the University of Minnesota will be included. The study does not restrict enrollment based on sex, gender, race, ethnicity, or other demographic factors. Non-demographic factors such as social determinants of health, socioeconomic status, and comorbidities will be considered in the study analysis.

Description

Inclusion Criteria:

• Adults aged >18 years.
• Diagnosis of NP based on CECT.

Exclusion Criteria:

• recurrent AP
• pancreatic cancer
• pregnancy, lactation
• solid organ transplant
• immunodeficiency disorders like AIDS.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; participants locally through the University of Minnesota and the M Health Fairview system before the two-week mark following acute pancreatitis onset	Other: not interventional; This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Understand immune-metabolic dynamics in NP	by assessing pro- and anti-inflammatory cytokines, immune response of peripheral blood mononuclear cells (PBMCs), and plasma metabolites	3 months
Identify novel biomarkers	Using venous blood samples	3 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Guru Trikudanatham, MD, University of Minnesota; Principal Investigator: Petr Vanek, MD, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Pancreatic Diseases; Necrosis; Pancreatitis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: DECISION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No