PAN-ICIS Study: ICIS for Early Detection of Infectious Complications in Pancreatic Surgery
NCT ID: NCT07248527
Last Updated: 2025-12-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Total Enrollment
400 participants
Study Classification
OBSERVATIONAL
Study Start Date
2025-11-01
Study Completion Date
2028-03-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Pancreatectomy
Pancreatic Surgery
Intensive Care (ICU)
Inflamatory Markers
Postoperative Care
Postoperative Pancreatic Fistula
Surgical Site Infection After Major Surgery
Postoperative Complications
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Patients following pancreatic surgery
All patients following pancreatic surgery will be enrolled in this study
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients ≥ 18-years-old
* Indication for an elective pancreatic procedure
* Written informed consent
* Indication for an elective pancreatic procedure
* Written informed consent
Exclusion Criteria
* Patients \<18 years old.
* Known hematologic malignancy or hematological pathology.
* Refusal to participate.
* Known hematologic malignancy or hematological pathology.
* Refusal to participate.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Charles University, Czech Republic
OTHER
Sponsor Role
lead
Responsible Party
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Štěpán-Ota Schütz
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Department of Surgery 2nd Faculty of Medicine, Charles University and Military University Hospital Prague
Prague, Prague 6, Czechia
Site Status
Countries
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Czechia
References
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Other Identifiers
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108/20-72/2025
Identifier Type: -
Identifier Source: org_study_id
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