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Venous Thromboembolism in Primary Pancreatic Tumour Resection

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05964621
Acronym
PaTR-VTE
Enrollment
64
Registered
2023-07-28
Start date
2023-09-01
Completion date
2024-10-01
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Venous Thromboembolism

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

Interventions

None listed

Sponsors

University of Thessaly
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Neutrophil to lymphocyte ratio-VTEup to 30rd postoperative dayThe 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
von Willebrand factor-VTEup to 30rd postoperative dayThe 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
Factors VIII and XI-VTEup to 30rd postoperative dayThe 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
D-dimers-VTEup to 30rd postoperative dayThe 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
Fibrinogen-VTEup to 30rd postoperative dayThe 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
Adams-13-VTEup to 30rd postoperative dayThe 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 resectionup to 30rd postoperative dayThe incidence of VTE in patients with primary pancreatic cancer undergoing pancreatic cancer resection

Countries

Greece

Contacts

Primary ContactEleni Arnaoutoglou, Professor
earnaout@gmail.com6974301352
Backup ContactMaria P Ntalouka, M.D., Ph.D, M.Sc.
maria.ntalouka@icloud.com6973688099

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026