Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07248527

PAN-ICIS Study: ICIS for Early Detection of Infectious Complications in Pancreatic Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreatectomy Infections Inflamatory Markers Inflammation Intensive Care (ICU) Pancreatic Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Care Postoperative Complications Postoperative Pancreatic Fistula Sepsis Surgical Site Infection After Major Surgery Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery 2nd Faculty of Medicine, Charles University and Military University Hospital Prague

Prague, Prague 6, 16902, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Primary outcome

    Time frame: 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 outcomes

  1. Secondary outcome

    Time frame: 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 outcomes

  1. Exploratory outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Acronym: PAN-ICIS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 25, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.