An observational study in Venous Thrombosis, Pulmonary Embolism and Hepatectomy, sponsored by Technische Universität Dresden. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-15.
Sponsored by Technische Universität Dresden · Observational
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.
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.
738 studies on the registry are indexed under Pulmonary Embolism; 158 are open to participants now.
This study's enrollment of 76 is below the median of 383 across 323 observational studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.
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Patients scheduled for elective oncological liver or pancreatic resection
Exclusion Criteria:
All patients will be screened for deep venous thrombosis on postoperative day 3. Patients with a positive finding will be grouped in arm "A"
All patients will be screened for deep venous thrombosis on postoperative day 3. Patients with a negative finding will be grouped in arm "B"
Deep venous thrombosis on day 3 after surgery
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.
Time frame: 3 days
Symptomatic deep venous thrombosis or pulmonary embolism during hospital stay
Patients who develop clinical signs of a DVT like swelling of the leg, pain or tenderness in the leg, increased warmth, red or discolored skin of the leg, will be diagnosed by complete compression duplex sonography for confirmation of a deep venous thrombosis. Patients who develop clinical signs of pulmonary embolism like unexplained shortness of breath, pain with deep breathing, coughing of blood, chest pain with electrocardiographic signs of right ventricular stress will be diagnosed by CT pulmonary angiography for confirmation of central or peripheral pulmonary embolism.
Time frame: 30 days
Plan to share: No
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This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Technische Universität Dresden