Venous Thromboembolism in Primary Pancreatic Tumour Resection (PaTR-VTE)

University of Thessaly

Status: Enrolling

Conditions: Venous Thromboembolism; Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05964621

24165

Details and patient eligibility

About

This study will evaluate the development of venous thromboembolism (VTE) and possible determinants in patients with primary pancreatic cancer undergoing pancreatic cancer resection.

Full description

Cancer associated thrombosis (CAT) is the second cause of death, in oncologic patients after tumour progression itself. Patients suffering from malignancies are at increased risk for both venous (4-20%) and arterial (2-5%) thrombotic events. Moreover, cancer is one of the most important acquired risk factors for the development of venous thromboembolism (VTE).

Pancreatic cancer is the fourth most deadly cancer world-widely and has been recognised as the most prothrombotic malignancy, with a reported incidence of VTE (8-18%), followed by renal and ovarian cancer (VTE 5.6%). Although the exact pathophysiological mechanisms are still poorly understood it seems that pancreatic cancer induces a prothrombotic and hypercoagulable state.

Aims

• To evaluate the predictive value of preoperatively or early postoperatively obtained NLR, in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day
• To evaluate the predictive value of preoperatively or early postoperatively obtained coagulation biomarkers/parameters, in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day
• To evaluate the incidence of VTE in patients with primary pancreatic cancer undergoing pancreatic cancer resection
• To assess the perioperative coagulation status of patients with primary pancreatic cancer undergoing pancreatic cancer resection
• To evaluate any possible determinant or predictive factor for VTE among the coagulation parameters or patients' baseline characteristics

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive pancreatic cancer patients undergoing pancreatic cancer resection in University Hospital of Larissa, after informed consent will be included.

Exclusion criteria

• Refuse to participate
• Previous thromboembolic event < 6 months prior to the operation
• History of inherited or acquired bleeding disorder
• ASA PS > 3
• Concomitant presence of a second primary malignancy
• Unresectable pancreatic cancer

Trial design

64 participants in 1 patient group

Pancreatic cancer patients undergoing pancreatic cancer resection

Description:

Perioperative laboratory examinations will follow institutional guidelines. These will include, but will not be limited to full blood count, conventional coagulation tests, liver function, and kidney function tests. Moreover, for the purpose of this study, the following parameters will also be obtained; vWF, factors VIII and XI, D-dimers, fibrinogen, platelets activation (multiplate), adams-13, anti-Xa and high sensitivity troponin. All samples will be obtained via puncture from a peripheral vein. Blood samples will obtained at three time points; preoperatively before induction to GA (01), early postoperatively in PACU (02) and postoperatively before discharge (10 days, 03). Of note, at 30 days our patients will undergo an evaluation for asymptomatic DVT with a US triplex scanner. In addition, any thromboembolic episode (deep vein thrombosis, pulmonary embolism) will also be recorded.