Acute PancreatitisNCT06899087
DEciphering CIrculating SIgnatures Of Infected Pancreatic Necrosis
An observational study of Acute Pancreatitis, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- not interventional
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults aged >18 years.
- Diagnosis of NP based on CECT.
Who cannot join
- recurrent AP
- pancreatic cancer
- pregnancy, lactation
- solid organ transplant
- immunodeficiency disorders like AIDS.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Petr Vanek, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Petr Vanek
About this study
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
- Being tested
- not interventional
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not interventionalOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Study group | participants locally through the University of Minnesota and the M Health Fairview system before the two-week mark following acute pancreatitis onset Receives: Other: not interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understand immune-metabolic dynamics in NP
by assessing pro- and anti-inflammatory cytokines, immune response of peripheral blood mononuclear cells (PBMCs), and plasma metabolites
Measured: 3 months
Identify novel biomarkers
Using venous blood samples
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Jul 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guru Trikudanatham, MD, Principal investigator, University of MinnesotaPetr Vanek, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899087
- Sponsor's protocol ID
- DECISION
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEciphering CIrculating SIgnatures Of Infected Pancreatic Necrosis
- ClinicalTrials.gov ID
- NCT06899087
- Acronym / sponsor ID
- DECISION
- Conditions
- Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: not interventionalparticipants locally through the University of Minnesota and the M Health Fairview system before the two-week mark following acute pancreatitis onset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults aged >18 years.
- Diagnosis of NP based on CECT.
Key exclusion criteria (5 listed)
- recurrent AP
- pancreatic cancer
- pregnancy, lactation
- solid organ transplant
- immunodeficiency disorders like AIDS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| not interventionalThis is an observational study | Other | Study group |
Primary outcome
Understand immune-metabolic dynamics in NP
Time frame: 3 months
by assessing pro- and anti-inflammatory cytokines, immune response of peripheral blood mononuclear cells (PBMCs), and plasma metabolites
Identify novel biomarkers
Time frame: 3 months
Using venous blood samples
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petr Vanek, MD, PhD contact
Guru Trikudanatham, MD principal investigator
University of Minnesota
Petr Vanek, MD, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petr Vanek, MD, PhD (pvanek@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understand immune-metabolic dynamics in NP (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.