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This study will evaluate the development of venous thromboembolism (VTE) and possible determinants in patients with primary pancreatic cancer undergoing pancreatic cancer resection.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Neutrophil to lymphocyte ratio-VTE | 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 | up to 30rd postoperative day |
| von Willebrand factor-VTE | 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 | up to 30rd postoperative day |
| Factors VIII and XI-VTE | 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 | up to 30rd postoperative day |
| D-dimers-VTE | 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 | up to 30rd postoperative day |
| Fibrinogen-VTE | 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 | up to 30rd postoperative day |
| Adams-13-VTE | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with primary pancreatic cancer are appropriately staged with high quality imaging according to the NCCN guidelines version 1.2023. Surgical resection is the only potentially curative technique for the management of pancreatic cancer. However, the median survival even of patients submitted to resection remains low, ranging between 15 and 19 months.
The negative margin status is probably the most important prognostic factor. Pancreatic tumours are classified as resectable, borderline resectable and unresectable based on the probability of attaining an R0 resection.In borderline resectable neoadjuvant chemotherapy is administered in these patients prior to resection. In regards to the Whipple's procedure, the aim is to preserve the pylorous while, performing a pancreaticojejunostomy for the reestablishment of the gastrointestinal tract continuity.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eleni Arnaoutoglou, Professor | Contact | 6974301352 | +30 | earnaout@gmail.com |
| Maria P Ntalouka, M.D., Ph.D, M.Sc. | Contact | 6973688099 | +30 | maria.ntalouka@icloud.com |
| Name | Affiliation | Role |
|---|---|---|
| Eleni M Arnaoutoglou, Professor | Dpt of Anaesthesiology | Study Chair |
| Dimitrios Zacharoulis, Professor | Dpt of Surgery | Principal Investigator |
| Paraskevi Kotsi, Asst Professor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Larissa | Recruiting | Larissa | Thessaly | 41110 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40287701 | Derived | Ntalouka MP, Symeonidis D, Kotsi P, Petinaki E, Matsagkas M, Tepetes K, Zacharoulis D, Arnaoutoglou EM. Venous thromboembolism in patients undergoing pancreatic cancer surgery (PaTR-VTE) with curative intent; protocol of a prospective observational study. BMC Surg. 2025 Apr 26;25(1):183. doi: 10.1186/s12893-024-02665-z. |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| up to 30rd postoperative day |
| VTE incidence in primary pancreatic cancer resection | The incidence of VTE in patients with primary pancreatic cancer undergoing pancreatic cancer resection | up to 30rd postoperative day |
| 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 | Principal Investigator |
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |