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

NCT07248527 | Active Not Recruiting

• 1 other identifier: 108/20-72/2025
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Intensive care infection score; pancreatic surgery; biomarkers; intensive care; sepsis; POPF; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  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).

  From day one after surgery to the end of hospitalization

Secondary Outcomes (1)

• Secondary outcome

  From day one after surgery to the end of the hospitalization

Other Outcomes (1)

• Exploratory outcomes

  From day one after surgery to the end of the 90 day follow-up

Study Arms (1)

Patients following pancreatic surgery

All patients following pancreatic surgery will be enrolled in this study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing pancreatic surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

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

Prague, Prague 6, 16902, Czechia

Location

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MeSH Terms

Conditions

Postoperative Complications; Sepsis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)