Clinical trial NCT05964621: Venous Thromboembolism in Primary Pancreatic Tumour Resection
Official title: Venous Thromboembolism in Patients Undergoing Primary Pancreatic Tumour Resection; a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Venous Thromboembolism
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility 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

Primary outcomes:
measure: Neutrophil to lymphocyte ratio-VTE
timeFrame: up to 30rd postoperative day
measure: von Willebrand factor-VTE
timeFrame: up to 30rd postoperative day
measure: Factors VIII and XI-VTE
timeFrame: up to 30rd postoperative day
measure: D-dimers-VTE
timeFrame: up to 30rd postoperative day
measure: Fibrinogen-VTE
timeFrame: up to 30rd postoperative day
measure: Adams-13-VTE
timeFrame: up to 30rd postoperative day
measure: VTE incidence in primary pancreatic cancer resection
timeFrame: up to 30rd postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa
state: Thessaly
Study officials:
affiliation: Dpt of Anaesthesiology
name: Eleni M Arnaoutoglou, Professor
role: STUDY_CHAIR
affiliation: Dpt of Surgery
name: Dimitrios Zacharoulis, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Dpt of Transfusion Medicine
name: Paraskevi Kotsi, Asst Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Dpt of Surgery
name: Dimitrios Symeonidis, Asst Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Dpt of Anaesthesiology
name: Maria P Ntalouka, M.D., Ph.D, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: