Venous Thromboembolism in Primary Pancreatic Tumour Resection
NCT ID: NCT05964621
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
64 participants
OBSERVATIONAL
2023-09-01
2024-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pancreatic cancer patients undergoing pancreatic cancer resection
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Thessaly
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Elena Arnaoutoglou
Professor of Anaesthesiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eleni M Arnaoutoglou, Professor
Role: STUDY_CHAIR
Dpt of Anaesthesiology
Dimitrios Zacharoulis, Professor
Role: PRINCIPAL_INVESTIGATOR
Dpt of Surgery
Paraskevi Kotsi, Asst Professor
Role: PRINCIPAL_INVESTIGATOR
Dpt of Transfusion Medicine
Dimitrios Symeonidis, Asst Professor
Role: PRINCIPAL_INVESTIGATOR
Dpt of Surgery
Maria P Ntalouka, M.D., Ph.D, M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Dpt of Anaesthesiology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital of Larissa
Larissa, Thessaly, Greece
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Ntalouka MP, Symeonidis D, Kotsi P, Petinaki E, Matsagkas M, Tepetes K, Zacharoulis D, Arnaoutoglou EM. Venous thromboembolism in patients undergoing pancreatic cancer surgery (PaTR-VTE) with curative intent; protocol of a prospective observational study. BMC Surg. 2025 Apr 26;25(1):183. doi: 10.1186/s12893-024-02665-z.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24165
Identifier Type: -
Identifier Source: org_study_id