Venous Thromboembolism in Primary Pancreatic Tumour Resection

Trial Title: Venous Thromboembolism in Primary Pancreatic Tumour Resection

NCT ID: NCT05964621

Condition: Venous Thromboembolism
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma

Conditions: Official terms:
Pancreatic Neoplasms
Thromboembolism
Venous Thromboembolism

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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

Criteria for eligibility:

Study pop:
Patients with primary pancreatic cancer are appropriately staged with high quality imaging according to the NCCN guidelines version 1.2023. Surgical resection is the only potentially curative technique for the management of pancreatic cancer. However, the median survival even of patients submitted to resection remains low, ranging between 15 and 19 months. The negative margin status is probably the most important prognostic factor. Pancreatic tumours are classified as resectable, borderline resectable and unresectable based on the probability of attaining an R0 resection.In borderline resectable neoadjuvant chemotherapy is administered in these patients prior to resection. In regards to the Whipple's procedure, the aim is to preserve the pylorous while, performing a pancreaticojejunostomy for the reestablishment of the gastrointestinal tract continuity.

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital of Larissa

Address:
City: Larissa
Zip: 41110
Country: Greece

Status: Recruiting

Contact:
Last name: Eleni Arnaoutoglou, M.D. Ph.D.

Phone: 6975301352
Email: earnaout@gmail.com

Start date: September 1, 2023

Completion date: October 1, 2024

Lead sponsor:
Agency: University of Thessaly
Agency class: Other

Source: University of Thessaly

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05964621