RECRUITING

DEciphering CIrculating SIgnatures Of Infected Pancreatic Necrosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

DEciphering CIrculating SIgnatures Of Infected Pancreatic Necrosis

Quick Facts

Study Start:2025-07-01
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06899087

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged \>18 years.
  2. * Diagnosis of NP based on CECT.
  1. * recurrent AP
  2. * pancreatic cancer
  3. * pregnancy, lactation
  4. * solid organ transplant
  5. * immunodeficiency disorders like AIDS.

Contacts and Locations

Study Contact

Petr Vanek, MD, PhD
CONTACT
pvanek@umn.edu

Principal Investigator

Guru Trikudanatham, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota
Petr Vanek, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Guru Trikudanatham, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota
  • Petr Vanek, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Pancreatitis