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2023-09-01
2024-09-01
2024-10-01
64
NCT05964621
University of Thessaly
University of Thessaly
OBSERVATIONAL
Venous Thromboembolism in Primary Pancreatic Tumour Resection
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 * 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 * 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 * To evaluate the incidence of VTE in patients with primary pancreatic cancer undergoing pancreatic cancer resection * To assess the perioperative coagulation status of patients with primary pancreatic cancer undergoing pancreatic cancer resection * To evaluate any possible determinant or predictive factor for VTE among the coagulation parameters or patients' baseline characteristics
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-07-03 | N/A | 2023-11-25 |
2023-07-27 | N/A | 2023-11-28 |
2023-07-28 | N/A | 2023-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/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 |
| Primary Outcome Measures | 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 | 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Eleni Arnaoutoglou, Professor Phone Number: 6974301352 Email: earnaout@gmail.com |
Study Contact Backup Name: Maria P Ntalouka, M.D., Ph.D, M.Sc. Phone Number: 6973688099 Email: maria.ntalouka@icloud.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
