Venous Thromboembolism in Primary Pancreatic Tumour Resection

Recruiting

• Conditions: Venous Thromboembolism; Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer

• Registration Number: NCT05964621
• Lead Sponsor: University of Thessaly

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-27
• Study First Posted: 2023-07-28
• Study Start: 2023-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-25
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-09-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fibrinogen-VTE	up to 30rd postoperative day	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
von Willebrand factor-VTE	up to 30rd postoperative day	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
D-dimers-VTE	up to 30rd postoperative day	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
Factors VIII and XI-VTE	up to 30rd postoperative day	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
Neutrophil to lymphocyte ratio-VTE	up to 30rd postoperative day	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
Adams-13-VTE	up to 30rd postoperative day	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
VTE incidence in primary pancreatic cancer resection	up to 30rd postoperative day	The incidence of VTE in patients with primary pancreatic cancer undergoing pancreatic cancer resection

Trial Locations

Locations (1)

University Hospital of Larissa; 🇬🇷 Larissa, Thessaly, Greece