PaTR-VTE: Venous Thromboembolism in Primary Pancreatic Tumour Resection
Study Details
Study Description
Brief Summary
This study will evaluate the development of venous thromboembolism (VTE) and possible determinants in patients with primary pancreatic cancer undergoing pancreatic cancer resection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Cancer associated thrombosis (CAT) is the second cause of death, in oncologic patients after tumour progression itself. Patients suffering from malignancies are at increased risk for both venous (4-20%) and arterial (2-5%) thrombotic events. Moreover, cancer is one of the most important acquired risk factors for the development of venous thromboembolism (VTE).
Pancreatic cancer is the fourth most deadly cancer world-widely and has been recognised as the most prothrombotic malignancy, with a reported incidence of VTE (8-18%), followed by renal and ovarian cancer (VTE 5.6%). Although the exact pathophysiological mechanisms are still poorly understood it seems that pancreatic cancer induces a prothrombotic and hypercoagulable state.
Aims
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To evaluate the predictive value of preoperatively or early postoperatively obtained NLR, in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day
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To evaluate the predictive value of preoperatively or early postoperatively obtained coagulation biomarkers/parameters, in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day
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To evaluate the incidence of VTE in patients with primary pancreatic cancer undergoing pancreatic cancer resection
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To assess the perioperative coagulation status of patients with primary pancreatic cancer undergoing pancreatic cancer resection
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To evaluate any possible determinant or predictive factor for VTE among the coagulation parameters or patients' baseline characteristics
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pancreatic cancer patients undergoing pancreatic cancer resection Perioperative laboratory examinations will follow institutional guidelines. These will include, but will not be limited to full blood count, conventional coagulation tests, liver function, and kidney function tests. Moreover, for the purpose of this study, the following parameters will also be obtained; vWF, factors VIII and XI, D-dimers, fibrinogen, platelets activation (multiplate), adams-13, anti-Xa and high sensitivity troponin. All samples will be obtained via puncture from a peripheral vein. Blood samples will obtained at three time points; preoperatively before induction to GA (01), early postoperatively in PACU (02) and postoperatively before discharge (10 days, 03). Of note, at 30 days our patients will undergo an evaluation for asymptomatic DVT with a US triplex scanner. In addition, any thromboembolic episode (deep vein thrombosis, pulmonary embolism) will also be recorded. |
Outcome Measures
Primary Outcome Measures
- Neutrophil to lymphocyte ratio-VTE [up to 30rd postoperative day]
The predictive value of preoperatively or early (10th day) postoperatively obtained neutrophil to lymphocyte ratio (NLR), in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day
- von Willebrand factor-VTE [up to 30rd postoperative day]
The predictive value of preoperatively or early (10th day) postoperatively obtained von Willebrand factor in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day
- Factors VIII and XI-VTE [up to 30rd postoperative day]
The predictive value of preoperatively or early (10th day) postoperatively obtained factors VIII and XI in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day
- D-dimers-VTE [up to 30rd postoperative day]
The predictive value of preoperatively or early (10th day) postoperatively obtained, D-dimers, in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day
- Fibrinogen-VTE [up to 30rd postoperative day]
The predictive value of preoperatively or early (10th day) postoperatively obtained, fibrinogen, in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day
- Adams-13-VTE [up to 30rd postoperative day]
The predictive value of preoperatively or early (10th day) postoperatively obtained adams-13 in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day
- VTE incidence in primary pancreatic cancer resection [up to 30rd postoperative day]
The incidence of VTE in patients with primary pancreatic cancer undergoing pancreatic cancer resection
Eligibility Criteria
Criteria
Inclusion Criteria:
- Consecutive pancreatic cancer patients undergoing pancreatic cancer resection in University Hospital of Larissa, after informed consent will be included.
Exclusion Criteria:
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Refuse to participate
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Previous thromboembolic event < 6 months prior to the operation
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History of inherited or acquired bleeding disorder
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ASA PS > 3
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Concomitant presence of a second primary malignancy
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Unresectable pancreatic cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Larissa | Larissa | Thessaly | Greece | 41110 |
Sponsors and Collaborators
- University of Thessaly
Investigators
- Study Chair: Eleni M Arnaoutoglou, Professor, Dpt of Anaesthesiology
- Principal Investigator: Dimitrios Zacharoulis, Professor, Dpt of Surgery
- Principal Investigator: Paraskevi Kotsi, Asst Professor, Dpt of Transfusion Medicine
- Principal Investigator: Dimitrios Symeonidis, Asst Professor, Dpt of Surgery
- Principal Investigator: Maria P Ntalouka, M.D., Ph.D, M.Sc., Dpt of Anaesthesiology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 24165