Venous Thromboembolism in Primary Pancreatic Tumour Resection

Pancreatic Cancer Clinical Trial

— PaTR-VTE  

Official title:

Venous Thromboembolism in Patients Undergoing Primary Pancreatic Tumour Resection; a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964621
• Other study ID #: 24165
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: November 2023
• Source: University of Thessaly
• Contact: Eleni Arnaoutoglou, Professor
• Phone: 6974301352
• Email: earnaout[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms
• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Greece	University Hospital of Larissa	Larissa	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutrophil to lymphocyte ratio-VTE	The predictive value of preoperatively or early (10th day) postoperatively obtained neutrophil to lymphocyte ratio (NLR), in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day	up to 30rd postoperative day
Primary	von Willebrand factor-VTE	The predictive value of preoperatively or early (10th day) postoperatively obtained von Willebrand factor in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day	up to 30rd postoperative day
Primary	Factors VIII and XI-VTE	The predictive value of preoperatively or early (10th day) postoperatively obtained factors VIII and XI in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day	up to 30rd postoperative day
Primary	D-dimers-VTE	The predictive value of preoperatively or early (10th day) postoperatively obtained, D-dimers, in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day	up to 30rd postoperative day
Primary	Fibrinogen-VTE	The predictive value of preoperatively or early (10th day) postoperatively obtained, fibrinogen, in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day	up to 30rd postoperative day
Primary	Adams-13-VTE	The predictive value of preoperatively or early (10th day) postoperatively obtained adams-13 in patients with primary pancreatic cancer undergoing pancreatic cancer resection, for VTE up to the 30rd postoperative day	up to 30rd postoperative day
Primary	VTE incidence in primary pancreatic cancer resection	The incidence of VTE in patients with primary pancreatic cancer undergoing pancreatic cancer resection	up to 30rd postoperative day