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

Charles University, Czech Republic

Status: Active, not recruiting

Conditions: Postoperative Complications; Pancreatic Surgery; Postoperative Care; Intensive Care (ICU); Postoperative Pancreatic Fistula; Inflamatory Markers; Pancreatectomy; Surgical Site Infection After Major Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT07248527

108/20-72/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

400 participants in 1 patient group

Patients following pancreatic surgery

Description:

All patients following pancreatic surgery will be enrolled in this study