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临床试验/NCT06899087
NCT06899087招募中不适用

DEciphering CIrculating SIgnatures Of Infected Pancreatic Necrosis

University of Minnesota1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
Understand immune-metabolic dynamics in NP

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged >18 years.
  • •Diagnosis of NP based on CECT.

排除标准

  • •recurrent AP
  • •pancreatic cancer
  • •pregnancy, lactation
  • •solid organ transplant
  • •immunodeficiency disorders like AIDS.

研究组 & 干预措施

Study group

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

干预措施: not interventional (Other)

结局指标

主要结局

Understand immune-metabolic dynamics in NP

时间窗: 3 months

by assessing pro- and anti-inflammatory cytokines, immune response of peripheral blood mononuclear cells (PBMCs), and plasma metabolites

Identify novel biomarkers

时间窗: 3 months

Using venous blood samples

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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