Presepsin as a Predictor for Postoperative Complications Following Pancreatic Resection
Primary Purpose
Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Blood draw
Sponsored by
About this trial
This is an interventional diagnostic trial for Postoperative Complications focused on measuring Pancreatic resection, POPF, Inflammatory response
Eligibility Criteria
Inclusion Criteria:
- Patients with any pancreatic pathology (benign and malign) requiring surgery
- Written informed consent
- >= 18 years
Exclusion Criteria:
- Pregnancy
- Patients who are not capable of giving informed consent (e.g. with existing medical trustee)
Sites / Locations
- Medical University of Innsbruck
Outcomes
Primary Outcome Measures
Presepsin
Correlation of Presespin values with postoperative complications, especially POPF.
Secondary Outcome Measures
Biomarker assessment
Correlation of different biomarkers (CRP, IL-1, IL-6, IL-8, Procalcitonin) with operation associated postoperative complications after pancreatic resections.
Full Information
NCT ID
NCT04294797
First Posted
March 2, 2020
Last Updated
March 2, 2020
Sponsor
Medical University Innsbruck
1. Study Identification
Unique Protocol Identification Number
NCT04294797
Brief Title
Presepsin as a Predictor for Postoperative Complications Following Pancreatic Resection
Official Title
Pilotstudie: Presepsin Als möglicher Prädiktor Postoperativer Komplikationen Nach Pankreasresektionen
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
August 26, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study investigates the local and systemic inflammatory response following pancreatic resections.
Detailed Description
Pancreatic resections (PR) are major hepato-pancreatico-biliary (HPB) surgeries associated with significant morbidity and mortality. Despite improvements in surgical technique, as well as peri- and postoperative care, mortality rates range from 2-5%, even in high volume centres. Moreover, morbidity rates after PR can be as high as 70%, especially when evaluated in a prospective setting. In this context, postoperative pancreatic fistula (POPF) represents one of the most frequent complications following PR, with a high variability in the literature ranging from 20% to 64%. Besides POPF, the most frequent complications following PR are delayed gastric emptying (DGE, 18%), postoperative fluid collections (10%), postoperative haemorrhage (PPH, 10%), wound infections (10%), or intra-abdominal abscesses (5%). All of these complications are often characterized by infection and sepsis, and despite all intensive-medical measures, associated with high mortality. In this context, early anticipation and appropriate treatment of clinically relevant grade B or C POPF (CR-POPF) is of utmost importance to prevent fatal outcome.
In order to aid with timely detection and therapy of potentially severe POPF, evaluation of predictive biomarkers that could be able to differentiate early between non-significant biochemical leaks and potentially severe CR-POPF is of urgent interest for all specialties involved in the treatment of pancreatic surgery patients.
Over the last decade, various biomarkers have already been assessed: Procalcitonin (PCT) is one of the most frequently used markers. It has advantages over common infection parameters such as CRP or white blood cells but is often altered in various forms of systemic inflammation and thus not precise enough for an accurate clinical assessment. Connor et al. proposed, that the early postoperative local inflammatory process (postoperative acute pancreatitis, POAP) represents one of the main determinants in POPF development and systemic response measured by CRP could predict severity of POPF. Moreover, in the LEOPARD-2 trial, higher postoperative IL-6 levels were found in patients with severe complications including CR-POPF, whereas IL-8 and CRP Levels in their series were comparable between groups.
More recently, also Presepsin (soluble CD14) showed promising results as a biomarker for sepsis diagnosis and postoperative complications but has never been assessed in the context of major HPB surgeries.
Early detection and therapy of potentially life-threatening complications following major HPB surgery is of urgent interest for all specialties involved in the treatment of these patients and studies investigating the predictive value of Presepsin and other inflammatory markers following PR are lacking. Accordingly, the aim of the present pilot study is to evaluate, for the first time, the kinetics of the biomarker Presepsin after PR and to predict the clinical course.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
Pancreatic resection, POPF, Inflammatory response
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood draw
Intervention Description
One additional blood sample for study purpose from the day before surgery, postoperative 1, 3 and 8.
Primary Outcome Measure Information:
Title
Presepsin
Description
Correlation of Presespin values with postoperative complications, especially POPF.
Time Frame
Preoperative until postoperative day 8.
Secondary Outcome Measure Information:
Title
Biomarker assessment
Description
Correlation of different biomarkers (CRP, IL-1, IL-6, IL-8, Procalcitonin) with operation associated postoperative complications after pancreatic resections.
Time Frame
Preoperative until postoperative day 8.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with any pancreatic pathology (benign and malign) requiring surgery
Written informed consent
>= 18 years
Exclusion Criteria:
Pregnancy
Patients who are not capable of giving informed consent (e.g. with existing medical trustee)
Facility Information:
Facility Name
Medical University of Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32901324
Citation
Gasteiger S, Primavesi F, Gobel G, Braunwarth E, Cardini B, Maglione M, Sopper S, Ofner D, Stattner S. Early Post-Operative Pancreatitis and Systemic Inflammatory Response Assessed by Serum Lipase and IL-6 Predict Pancreatic Fistula. World J Surg. 2020 Dec;44(12):4236-4244. doi: 10.1007/s00268-020-05768-9. Epub 2020 Sep 8.
Results Reference
derived
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Presepsin as a Predictor for Postoperative Complications Following Pancreatic Resection
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