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临床试验/NCT07248527
NCT07248527进行中(未招募)不适用

PAN-ICIS: Prospective Observational Study Evaluating the Intensive Care Infection Score for Early Detection of Infectious Complications After Pancreatic Resections

Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
400
试验地点
1
主要终点
Primary outcome

研究概览

简要总结

This study examines a new blood test called ICIS, which may help detect infections earlier after pancreatic surgery. Patients will have routine blood samples taken during their hospital stay, with no extra procedures required. By tracking how ICIS changes over time, investigators aim to improve early infection detection, support safer recovery, and reduce postoperative complications.

详细描述

Pancreatic resections carry a high burden of postoperative morbidity, particularly due to complications such as pancreatic fistula and bile leakage, which frequently lead to intra-abdominal infection and sepsis. Early diagnosis remains difficult because conventional inflammatory markers (CRP, WBC, PCT, IL-6) lack specificity and are often elevated due to postoperative SIRS. The Intensive Care Infection Score (ICIS) has demonstrated superior performance in distinguishing SIRS from sepsis in surgical patients.

The PAN-ICIS study is a prospective observational study enrolling patients undergoing pancreatic resections. ICIS will be measured postoperatively and compared with conventional inflammatory markers. Perioperative variables, postoperative complications, and infectious outcomes will be collected prospectively. Accurate early differentiation between SIRS and sepsis represents a major need in pancreatic surgery. This study will evaluate the diagnostic accuracy and clinical utility of ICIS for early detection of postoperative infectious complications. If validated, ICIS may support earlier antimicrobial therapy, reduce unnecessary antibiotic exposure, and improve postoperative outcomes in this high-risk population.

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

入选标准

  • Patients ≥ 18-years-old
  • Indication for an elective pancreatic procedure
  • Written informed consent

排除标准

  • Patients <18 years old.
  • Known hematologic malignancy or hematological pathology.
  • Refusal to participate.

结局指标

主要结局

Primary outcome

时间窗: From day one after surgery to the end of hospitalization

Diagnostic accuracy of ICIS for detecting postoperative infectious complications, measured by area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, positive and negative predictive values, and likelihood ratios at prespecified cut-offs (e.g., ≥3, ≥4, ≥5).

次要结局

  • Secondary outcome(From day one after surgery to the end of the hospitalization)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Štěpán-Ota Schütz

Principal Investigator

Charles University, Czech Republic

研究点 (1)

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