NCT06899087 DEciphering CIrculating SIgnatures Of Infected Pancreatic Necrosis
| NCT ID | NCT06899087 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Acute Pancreatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2025-07-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Petr Vanek, MD, PhD
✉ pvanek@umn.eduGuru Trikudanatham, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06899087 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06899087 currently recruiting?
Yes, NCT06899087 is actively recruiting participants. Contact the research team at pvanek@umn.edu for enrollment information.
Where is the NCT06899087 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06899087 clinical trial?
NCT06899087 is sponsored by University of Minnesota. The principal investigator is Guru Trikudanatham, MD at University of Minnesota. The trial plans to enroll 45 participants.