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临床试验/NCT02649023
NCT02649023终止不适用

Pre- and Early Postoperative Deep Venous Thrombosis in Patients Undergoing Oncological Hepatic or Panreatic Resection

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
76
试验地点
1
主要终点
Deep venous thrombosis on day 3 after surgery

研究概览

简要总结

To investigate the incidence of pre- and early postoperative deep venous thrombosis in patients undergoing hepatobiliopancreatic surgery, as well as potential corresponding risk factors with special attention to circulating tumor cells.

详细描述

Thromboembolic events are a common cause of morbidity and mortality in oncological patients. Up to 20% of cancer patients suffer from venous thromboembolism (VTE) induced by the underlying malignancy itself. Oncologic gastrointestinal surgery is a well-known risk factor for VTE. About 4-6% of patients undergoing elective hepatobiliopanreatic surgery develop a deep venous thrombosis (DVT) or pulmonary embolism. However, there are no data referring to the incidence of DVT shortly ahead of the surgical event, implementing that a certain percentage of postoperative DVT might have already been acquired before the operation. Furthermore, most studies only evaluate the rate of symptomatic VTE. In this study, all patients undergoing hepatobiliopancreatic surgery will be screened for deep venous thrombosis the day before surgery, on the third postoperative day (primary endpoint) and 90 days after the operation with a 2-point compression sonography of the lower extremities. The development of a symptomatic VTE (DVT or pulmonary embolism) will be recorded as secondary endpoint. Risk factors, perioperative morbidity / mortality and presence of circulating tumor cells will be analyzed with regard to VTE incidence.

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

入选标准

  • Patients scheduled for elective oncological liver or pancreatic resection
  • Age equal or greater than 18 years
  • Written informed consent

排除标准

  • Preexistent coagulopathy
  • History of previous VTE
  • benign disease

结局指标

主要结局

Deep venous thrombosis on day 3 after surgery

时间窗: 3 days

Patients will be screened for deep venous thrombosis using a compression ultrasonography at the popliteal and common femoral vein. In case of a pathological finding, a complete compression duplex sonography of the lower extremities will be used for specification.

次要结局

  • Symptomatic deep venous thrombosis or pulmonary embolism during hospital stay(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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