Deep Venous Thrombosis After Hepatobiliopancreatic Surgery

NCT ID: NCT02649023

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-04-30

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.

Conditions

Venous Thrombosis; Pulmonary Embolism; Hepatectomy; Pancreatectomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A: Patients with deep venous thrombosis

All patients will be screened for deep venous thrombosis on postoperative day 3. Patients with a positive finding will be grouped in arm "A"

No interventions assigned to this group

B: Patients without deep venous thrombosis

All patients will be screened for deep venous thrombosis on postoperative day 3. Patients with a negative finding will be grouped in arm "B"

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nuh Rahbari, MD

Role: PRINCIPAL_INVESTIGATOR

Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden

Locations

Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU

Dresden, , Germany

Countries

Germany

Other Identifiers

VTG-05

Identifier Type: -

Identifier Source: org_study_id