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Clinical Trials/NCT02649023
NCT02649023TerminatedNot Applicable

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

Technische Universität Dresden1 site in 1 country76 target enrollmentStarted: January 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
76
Locations
1
Primary Endpoint
Deep venous thrombosis on day 3 after surgery

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Preexistent coagulopathy
  • History of previous VTE
  • benign disease

Outcomes

Primary Outcomes

Deep venous thrombosis on day 3 after surgery

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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