xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05964621</url>
    </required_header>
    <id_info>
      <org_study_id>24165</org_study_id>
      <nct_id>NCT05964621</nct_id>
    </id_info>
    <brief_title>Venous Thromboembolism in Primary Pancreatic Tumour Resection</brief_title>
    <acronym>PaTR-VTE</acronym>
    <official_title>Venous Thromboembolism in Patients Undergoing Primary Pancreatic Tumour Resection; a Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Thessaly</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Thessaly</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will evaluate the development of venous thromboembolism (VTE) and possible&#xD;
        determinants in patients with primary pancreatic cancer undergoing pancreatic cancer&#xD;
        resection.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cancer associated thrombosis (CAT) is the second cause of death, in oncologic patients after&#xD;
        tumour progression itself. Patients suffering from malignancies are at increased risk for&#xD;
        both venous (4-20%) and arterial (2-5%) thrombotic events. Moreover, cancer is one of the&#xD;
        most important acquired risk factors for the development of venous thromboembolism (VTE).&#xD;
  &#xD;
        Pancreatic cancer is the fourth most deadly cancer world-widely and has been recognised as&#xD;
        the most prothrombotic malignancy, with a reported incidence of VTE (8-18%), followed by&#xD;
        renal and ovarian cancer (VTE 5.6%). Although the exact pathophysiological mechanisms are&#xD;
        still poorly understood it seems that pancreatic cancer induces a prothrombotic and&#xD;
        hypercoagulable state.&#xD;
  &#xD;
        Aims&#xD;
  &#xD;
          -  To evaluate the predictive value of preoperatively or early postoperatively obtained&#xD;
             NLR, in patients with primary pancreatic cancer undergoing pancreatic cancer resection,&#xD;
             for VTE up to the 30rd postoperative day&#xD;
  &#xD;
          -  To evaluate the predictive value of preoperatively or early postoperatively obtained&#xD;
             coagulation biomarkers/parameters, in patients with primary pancreatic cancer undergoing&#xD;
             pancreatic cancer resection, for VTE up to the 30rd postoperative day&#xD;
  &#xD;
          -  To evaluate the incidence of VTE in patients with primary pancreatic cancer undergoing&#xD;
             pancreatic cancer resection&#xD;
  &#xD;
          -  To assess the perioperative coagulation status of patients with primary pancreatic&#xD;
             cancer undergoing pancreatic cancer resection&#xD;
  &#xD;
          -  To evaluate any possible determinant or predictive factor for VTE among the coagulation&#xD;
             parameters or patients' baseline characteristics&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Neutrophil to lymphocyte ratio-VTE</measure>
      <time_frame>up to 30rd postoperative day</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>von Willebrand factor-VTE</measure>
      <time_frame>up to 30rd postoperative day</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Factors VIII and XI-VTE</measure>
      <time_frame>up to 30rd postoperative day</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>D-dimers-VTE</measure>
      <time_frame>up to 30rd postoperative day</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fibrinogen-VTE</measure>
      <time_frame>up to 30rd postoperative day</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adams-13-VTE</measure>
      <time_frame>up to 30rd postoperative day</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>VTE incidence in primary pancreatic cancer resection</measure>
      <time_frame>up to 30rd postoperative day</time_frame>
      <description>The incidence of VTE in patients with primary pancreatic cancer undergoing pancreatic cancer resection</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Venous Thromboembolism</condition>
    <condition>Pancreatic Cancer</condition>
    <condition>Pancreatic Ductal Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>Pancreatic cancer patients undergoing pancreatic cancer resection</arm_group_label>
      <description>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.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with primary pancreatic cancer are appropriately staged with high quality imaging&#xD;
          according to the NCCN guidelines version 1.2023. Surgical resection is the only potentially&#xD;
          curative technique for the management of pancreatic cancer. However, the median survival&#xD;
          even of patients submitted to resection remains low, ranging between 15 and 19 months.&#xD;
  &#xD;
          The negative margin status is probably the most important prognostic factor. Pancreatic&#xD;
          tumours are classified as resectable, borderline resectable and unresectable based on the&#xD;
          probability of attaining an R0 resection.In borderline resectable neoadjuvant chemotherapy&#xD;
          is administered in these patients prior to resection. In regards to the Whipple's&#xD;
          procedure, the aim is to preserve the pylorous while, performing a pancreaticojejunostomy&#xD;
          for the reestablishment of the gastrointestinal tract continuity.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Consecutive pancreatic cancer patients undergoing pancreatic cancer resection in&#xD;
               University Hospital of Larissa, after informed consent will be included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refuse to participate&#xD;
  &#xD;
            -  Previous thromboembolic event &lt; 6 months prior to the operation&#xD;
  &#xD;
            -  History of inherited or acquired bleeding disorder&#xD;
  &#xD;
            -  ASA PS &gt; 3&#xD;
  &#xD;
            -  Concomitant presence of a second primary malignancy&#xD;
  &#xD;
            -  Unresectable pancreatic cancer&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eleni M Arnaoutoglou, Professor</last_name>
      <role>Study Chair</role>
      <affiliation>Dpt of Anaesthesiology</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Dimitrios Zacharoulis, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dpt of Surgery</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Paraskevi Kotsi, Asst Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dpt of Transfusion Medicine</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Dimitrios Symeonidis, Asst Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dpt of Surgery</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Maria P Ntalouka, M.D., Ph.D, M.Sc.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dpt of Anaesthesiology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eleni Arnaoutoglou, Professor</last_name>
      <phone>6974301352</phone>
      <phone_ext>+30</phone_ext>
      <email>earnaout@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Maria P Ntalouka, M.D., Ph.D, M.Sc.</last_name>
      <phone>6973688099</phone>
      <phone_ext>+30</phone_ext>
      <email>maria.ntalouka@icloud.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital of Larissa</name>
        <address>
          <city>Larissa</city>
          <state>Thessaly</state>
          <zip>41110</zip>
          <country>Greece</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Greece</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Thessaly</investigator_affiliation>
      <investigator_full_name>Elena Arnaoutoglou</investigator_full_name>
      <investigator_title>Professor of Anaesthesiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pancreatic Neoplasms</mesh_term>
      <mesh_term>Thromboembolism</mesh_term>
      <mesh_term>Venous Thromboembolism</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05964621
  org study id: 24165
  nct id: NCT05964621
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will evaluate the development of venous thromboembolism (VTE) and possible
        determinants in patients with primary pancreatic cancer undergoing pancreatic cancer
        resection.
  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
  observational model: Cohort
  time perspective: Prospective
  measure: Neutrophil to lymphocyte ratio-VTE
  time frame: up to 30rd postoperative day
  description: 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
  measure: von Willebrand factor-VTE
  time frame: up to 30rd postoperative day
  description: 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
  measure: Factors VIII and XI-VTE
  time frame: up to 30rd postoperative day
  description: 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
  measure: D-dimers-VTE
  time frame: up to 30rd postoperative day
  description: 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
  measure: Fibrinogen-VTE
  time frame: up to 30rd postoperative day
  description: 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
  measure: Adams-13-VTE
  time frame: up to 30rd postoperative day
  description: 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
  measure: VTE incidence in primary pancreatic cancer resection
  time frame: up to 30rd postoperative day
  description: The incidence of VTE in patients with primary pancreatic cancer undergoing pancreatic cancer resection
  arm group label: Pancreatic cancer patients undergoing pancreatic cancer resection
  description: 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.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Eleni M Arnaoutoglou, Professor
  role: Study Chair
  affiliation: Dpt of Anaesthesiology
  last name: Dimitrios Zacharoulis, Professor
  role: Principal Investigator
  affiliation: Dpt of Surgery
  last name: Paraskevi Kotsi, Asst Professor
  role: Principal Investigator
  affiliation: Dpt of Transfusion Medicine
  last name: Dimitrios Symeonidis, Asst Professor
  role: Principal Investigator
  affiliation: Dpt of Surgery
  last name: Maria P Ntalouka, M.D., Ph.D, M.Sc.
  role: Principal Investigator
  affiliation: Dpt of Anaesthesiology
  last name: Eleni Arnaoutoglou, Professor
  phone: 6974301352
  phone ext: +30
  email: earnaout@gmail.com
  last name: Maria P Ntalouka, M.D., Ph.D, M.Sc.
  phone: 6973688099
  phone ext: +30
  email: maria.ntalouka@icloud.com
  facility: 
  country: Greece
  responsible party type: Principal Investigator
  investigator affiliation: University of Thessaly
  investigator full name: Elena Arnaoutoglou
  investigator title: Professor of Anaesthesiology
  mesh term: Pancreatic Neoplasms
  mesh term: Thromboembolism
  mesh term: Venous Thromboembolism