Venous Thromboembolism in Primary Pancreatic Tumour Resection

NCT05964621 | Unknown

• 1 other identifier: 24165
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism; Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (7)

• Neutrophil to lymphocyte ratio-VTE

  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

  up to 30rd postoperative day

• von Willebrand factor-VTE

  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

  up to 30rd postoperative day

• Factors VIII and XI-VTE

  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

  up to 30rd postoperative day

• D-dimers-VTE

  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

  up to 30rd postoperative day

• Fibrinogen-VTE

  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

  up to 30rd postoperative day

• Adams-13-VTE

  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

  up to 30rd postoperative day

• VTE incidence in primary pancreatic cancer resection

  The incidence of VTE in patients with primary pancreatic cancer undergoing pancreatic cancer resection

  up to 30rd postoperative day

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Consecutive pancreatic cancer patients undergoing pancreatic cancer resection in University Hospital of Larissa, after informed consent will be included.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University Hospital of Larissa

Larissa, Thessaly, 41110, Greece

RECRUITING

Related Publications (1)

• 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.

  PMID: 40287701 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Eleni M Arnaoutoglou, Professor

  Dpt of Anaesthesiology

  STUDY CHAIR

• Dimitrios Zacharoulis, Professor

  Dpt of Surgery

  PRINCIPAL INVESTIGATOR

• Paraskevi Kotsi, Asst Professor

  Dpt of Transfusion Medicine

  PRINCIPAL INVESTIGATOR

• Dimitrios Symeonidis, Asst Professor

  Dpt of Surgery

  PRINCIPAL INVESTIGATOR

• Maria P Ntalouka, M.D., Ph.D, M.Sc.

  Dpt of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleni Arnaoutoglou, Professor

CONTACT

6974301352; earnaout@gmail.com

Maria P Ntalouka, M.D., Ph.D, M.Sc.

CONTACT

6973688099; maria.ntalouka@icloud.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesiology

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 28, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

GR (1)