Recruiting

Biomarkers for IPN

Sponsor:

University of Minnesota

Code:

NCT06899087

Conditions

Acute Pancreatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

not interventional

Study Details

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

Study ID

NCT06899087

Start date

Jul 1, 2025

Status verified date

Sep, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

Study group

participants locally through the University of Minnesota and the M Health Fairview system before the two-week mark following acute pancreatitis onset

Interventions

not interventional

This is an observational study

Primary outcome measure

  • Understand immune-metabolic dynamics in NP [ Time Frame: 3 months ]
  • Identify novel biomarkers [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Petr Vanek, MD, PhD

pvanek@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

More Information

Sponsor

University of Minnesota

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-09-03.