Deep Venous Thrombosis After Hepatobiliopancreatic Surgery

Pulmonary Embolism Clinical Trial

— POPLITEA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02649023
• Other study ID #: VTG-05
• Status: Terminated
• Start date: January 2016
• Est. completion date: April 2018

Study information

• Verified date: March 2019
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 76
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Hepatectomy
• Pancreatectomy
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Germany	Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 days
Secondary	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.	30 days