Venous Thromboembolism in Patients Undergoing Primary Pancreatic Tumour Resection; a Prospective Observational Study

University of Thessaly1 个研究点分布在 1 个国家目标入组 64 人开始时间: 2023年9月1日最近更新: 2023年11月28日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: University of Thessaly
入组人数: 64
试验地点: 1
主要终点: Fibrinogen-VTE

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Consecutive pancreatic cancer patients undergoing pancreatic cancer resection in University Hospital of Larissa, after informed consent will be included.

排除标准

•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