Deep Venous Thrombosis After Hepatobiliopancreatic Surgery

Terminated

• Conditions: Venous Thrombosis; Hepatectomy; Pulmonary Embolism; Pancreatectomy

• Registration Number: NCT02649023
• Lead Sponsor: Technische Universität Dresden

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 Timeline

• Study First Submitted: 2015-12-07
• Study Start: 2016-01
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-07
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Deep venous thrombosis on day 3 after surgery	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 Outcome Measures

Name	Time	Method
Symptomatic deep venous thrombosis or pulmonary embolism during hospital stay	30 days	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.

Trial Locations

Locations (1)

Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU; 🇩🇪 Dresden, Germany