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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05964621
Other study ID # 24165
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date October 1, 2024

Study information

Verified date November 2023
Source University of Thessaly
Contact Eleni Arnaoutoglou, Professor
Phone 6974301352
Email earnaout@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will evaluate the development of venous thromboembolism (VTE) and possible determinants in patients with primary pancreatic cancer undergoing pancreatic cancer resection.


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 - 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


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date October 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Consecutive pancreatic cancer patients undergoing pancreatic cancer resection in University Hospital of Larissa, after informed consent will be included. Exclusion Criteria: - Refuse to participate - Previous thromboembolic event < 6 months prior to the operation - History of inherited or acquired bleeding disorder - ASA PS > 3 - Concomitant presence of a second primary malignancy - Unresectable pancreatic cancer

Study Design


Locations

Country Name City State
Greece University Hospital of Larissa Larissa Thessaly

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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