DEciphering CIrculating SIgnatures Of Infected Pancreatic Necrosis

NCT06899087 | Recruiting

• 1 other identifier: DECISION
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

not interventional OTHER

This is an observational study

Study group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood samples will be collected

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Guru Trikudanatham, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Petr Vanek, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petr Vanek, MD, PhD

CONTACT

pvanek@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 27, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

US (1)