Inflamatory Markers, Intensive Care (ICU), Pancreatectomy, Pancreatic Surgery, Postoperative Care, Postoperative Complications, Postoperative Pancreatic Fistula, Surgical Site Infection After Major Surgery
Conditions
Keywords
Intensive care infection score, pancreatic surgery, biomarkers, intensive care, sepsis, POPF, Postoperative complications
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Charles University, Czech Republic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18-years-old * Indication for an elective pancreatic procedure * Written informed consent
Exclusion criteria
* Patients \<18 years old. * Known hematologic malignancy or hematological pathology. * Refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcome | From day one after surgery to the end of the hospitalization | Comparative diagnostic performance of ICIS vs. CRP, PCT, and IL-6; time-to-diagnosis; and the incremental value of ICIS in multivariable models. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory outcomes | From day one after surgery to the end of the 90 day follow-up | Association of ICIS dynamics with POPF, SSI (superficial/deep/organ-space), bile leak, and anastomotic dehiscence; impact on antibiotic use (duration, de-escalation, escalation) and stewardship metrics; need for radiologic or surgical intervention; length of stay; readmission; and 90-day mortality. |
Countries
Czechia
Outcome results
None listed