Skip to content

DEciphering CIrculating SIgnatures Of Infected Pancreatic Necrosis

DEciphering CIrculating SIgnatures Of Infected Pancreatic Necrosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06899087
Enrollment
45
Registered
2025-03-27
Start date
2025-07-01
Completion date
2027-12-01
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis

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.

Interventions

This is an observational study

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Understand immune-metabolic dynamics in NP3 monthsby assessing pro- and anti-inflammatory cytokines, immune response of peripheral blood mononuclear cells (PBMCs), and plasma metabolites
Identify novel biomarkers3 monthsUsing venous blood samples

Countries

United States

Contacts

CONTACTPetr Vanek, MD, PhD
pvanek@umn.edu
PRINCIPAL_INVESTIGATORGuru Trikudanatham, MD

University of Minnesota

PRINCIPAL_INVESTIGATORPetr Vanek, MD, PhD

University of Minnesota

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026