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PancreatectomyPAN-ICISNCT07248527

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

An observational study of Pancreatectomy and Pancreatic Surgery, run by Charles University, Czech Republic at 1 site in Czechia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
400 participants
Where
1 siteCzechia
Study dates
1 Nov 2025to 31 Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing pancreatic surgery

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Czechia1 site

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

    Prague, Prague 6, 16902

Other trials in Czechia

About this study

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

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.

Read the 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.

Keywords
Intensive care infection score, pancreatic surgery, biomarkers, intensive care, sepsis, POPF, Postoperative complications
Medical subject headings
Postoperative Complications, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07248527
Study groupRoleWhat they receive
Patients following pancreatic surgeryAll patients following pancreatic surgery will be enrolled in this study

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From day one after surgery to the end of hospitalization

Secondary outcomes (1)

  1. Secondary outcome

    Comparative diagnostic performance of ICIS vs. CRP, PCT, and IL-6; time-to-diagnosis; and the incremental value of ICIS in multivariable models.

    Measured: From day one after surgery to the end of the hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2025
  2. Study start1 Nov 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07248527
Sponsor's protocol ID
108/20-72/2025
Acronym
PAN-ICIS
Status last verified
Nov 2025
First submitted
18 Nov 2025
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bilimoria KY, Liu Y, Paruch JL, Zhou L, Kmiecik TE, Ko CY, Cohen ME. Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons. J Am Coll Surg. 2013 Nov;217(5):833-42.e1-3. doi: 10.1016/j.jamcollsurg.2013.07.385. Epub 2013 Sep 18.

    PubMed 24055383

  • Cosgrove SE. The relationship between antimicrobial resistance and patient outcomes: mortality, length of hospital stay, and health care costs. Clin Infect Dis. 2006 Jan 15;42 Suppl 2:S82-9. doi: 10.1086/499406.

    PubMed 16355321

  • de Kraker ME, Wolkewitz M, Davey PG, Koller W, Berger J, Nagler J, Icket C, Kalenic S, Horvatic J, Seifert H, Kaasch A, Paniara O, Argyropoulou A, Bompola M, Smyth E, Skally M, Raglio A, Dumpis U, Melbarde Kelmere A, Borg M, Xuereb D, Ghita MC, Noble M, Kolman J, Grabljevec S, Turner D, Lansbury L, Grundmann H. Burden of antimicrobial resistance in European hospitals: excess mortality and length of hospital stay associated with bloodstream infections due to Escherichia coli resistant to third-generation cephalosporins. J Antimicrob Chemother. 2011 Feb;66(2):398-407. doi: 10.1093/jac/dkq412. Epub 2010 Nov 23.

    PubMed 21106563

  • Pierrakos C, Vincent JL. Sepsis biomarkers: a review. Crit Care. 2010;14(1):R15. doi: 10.1186/cc8872. Epub 2010 Feb 9.

    PubMed 20144219

  • Limongelli P, Pai M, Bansi D, Thiallinagram A, Tait P, Jackson J, Habib NA, Williamson RC, Jiao LR. Correlation between preoperative biliary drainage, bile duct contamination, and postoperative outcomes for pancreatic surgery. Surgery. 2007 Sep;142(3):313-8. doi: 10.1016/j.surg.2007.04.022.

    PubMed 17723881

  • Nakamura K, Sho M, Kinoshita S, Akahori T, Nagai M, Nakagawa K, Takagi T, Ikeda N. New insight into the association between bile infection and clinically relevant pancreatic fistula in patients undergoing pancreatoduodenectomy. J Hepatobiliary Pancreat Sci. 2020 Dec;27(12):992-1001. doi: 10.1002/jhbp.781. Epub 2020 Jul 2.

    PubMed 32506812

  • Ohgi K, Sugiura T, Yamamoto Y, Okamura Y, Ito T, Uesaka K. Bacterobilia may trigger the development and severity of pancreatic fistula after pancreatoduodenectomy. Surgery. 2016 Sep;160(3):725-30. doi: 10.1016/j.surg.2016.03.032. Epub 2016 May 24.

    PubMed 27233637

  • Loos M, Strobel O, Legominski M, Dietrich M, Hinz U, Brenner T, Heininger A, Weigand MA, Buchler MW, Hackert T. Postoperative pancreatic fistula: Microbial growth determines outcome. Surgery. 2018 Dec;164(6):1185-1190. doi: 10.1016/j.surg.2018.07.024. Epub 2018 Sep 11.

    PubMed 30217397

  • Droogh DHM, Groen JV, de Boer MGJ, van Prehn J, Putter H, Bonsing BA, van Eijck CHJ, Vahrmeijer AL, van Santvoort HC, Groot Koerkamp B, Mieog JSD. Prolonged antibiotic prophylaxis after pancreatoduodenectomy: systematic review and meta-analysis. Br J Surg. 2023 Oct 10;110(11):1458-1466. doi: 10.1093/bjs/znad213.

    PubMed 37440361

  • Nahm CB, Connor SJ, Samra JS, Mittal A. Postoperative pancreatic fistula: a review of traditional and emerging concepts. Clin Exp Gastroenterol. 2018 Mar 15;11:105-118. doi: 10.2147/CEG.S120217. eCollection 2018.

    PubMed 29588609

  • Saito R, Kawaida H, Amemiya H, Nakata Y, Izumo W, Furuya M, Maruyama S, Takiguchi K, Shoda K, Ashizawa N, Nakayama Y, Shiraishi K, Furuya S, Akaike H, Kawaguchi Y, Ichikawa D. Clinical significance of postoperative complications after pancreatic surgery in time-to-complication and length of postoperative hospital stay: a retrospective study. Langenbecks Arch Surg. 2024 Jun 5;409(1):173. doi: 10.1007/s00423-024-03369-x.

    PubMed 38836878

  • Sankar V, Webster NR. Clinical application of sepsis biomarkers. J Anesth. 2013 Apr;27(2):269-83. doi: 10.1007/s00540-012-1502-7. Epub 2012 Oct 30.

    PubMed 23108494

  • Aloisio E, Dolci A, Panteghini M. Procalcitonin: Between evidence and critical issues. Clin Chim Acta. 2019 Sep;496:7-12. doi: 10.1016/j.cca.2019.06.010. Epub 2019 Jun 10.

    PubMed 31194966

  • Leboueny M, Maloupazoa Siawaya AC, Bouanga LDJ, Mvoundza Ndjindji O, Mveang Nzoghe A, Djoba Siawaya JF. Changes of C-reactive protein and Procalcitonin after four weeks of treatment in patients with pulmonary TB. J Clin Tuberc Other Mycobact Dis. 2023 Jan 18;31:100348. doi: 10.1016/j.jctube.2023.100348. eCollection 2023 May.

    PubMed 36714271

  • Yu CW, Juan LI, Wu MH, Shen CJ, Wu JY, Lee CC. Systematic review and meta-analysis of the diagnostic accuracy of procalcitonin, C-reactive protein and white blood cell count for suspected acute appendicitis. Br J Surg. 2013 Feb;100(3):322-9. doi: 10.1002/bjs.9008. Epub 2012 Nov 30.

    PubMed 23203918

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatectomy and Pancreatic Surgery, run by Charles University, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary outcome (time frame: From day one after surgery to the end of hospitalization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07248527, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.

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