<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/NCT04402749</url>
  </required_header>
  <id_info>
    <org_study_id>2020_2</org_study_id>
    <nct_id>NCT04402749</nct_id>
  </id_info>
  <brief_title>The Incidence of Pulmonary Embolism During Nephrectomy</brief_title>
  <official_title>The Incidence of Perioperative Pulmonary Embolism in Patients With Renal Carcinoma Undergoing Nephrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</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>
      Patients with renal carcinoma was reported at high incidence of perioperative pulmonary&#xD;
      embolism from current study. The investigators aimed to determine the incidence and outcome&#xD;
      of this group of patient in the tertiary-care, university hospital and the rate of&#xD;
      intraoperative transesophageal echocardiography utility and outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Perioperative pulmonary embolism (PE) is the serious adverse event leading to major morbidity&#xD;
      and mortality. The incidence of PE during urologic surgery was previously report at 0.9 -&#xD;
      1.1% with mortality rate less than 2%. But the recent study by Fukazawa et al report the&#xD;
      incidence of PE was 11% in renal cancer patients underwent nephrectomy with mortality rate as&#xD;
      high as 33%. The risk factors associated with PE included major surgery, cancer, arrhythmia,&#xD;
      massive bleeding and level of tumor thrombus in inferior vena cava.&#xD;
&#xD;
      Transesophageal echocardiography (TEE) is a very helpful intraoperative monitoring tool in&#xD;
      major, non-cardiac surgery to detect emboli and guide the hemodynamic management in severely&#xD;
      unstable patients. But it requires sophisticate machine and well-trained operator, the rate&#xD;
      of utilisation was still limited.&#xD;
&#xD;
      The investigators aimed to determine the incidence of perioperative PE in renal cancer&#xD;
      patients undergoing nephrectomy. the secondary outcomes include risk factors associated with&#xD;
      perioperative PE, clinical outcomes, the rate of TEE utilization in this operation and&#xD;
      outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of intraoperative PE of renal cancer patient undergoing nephrectomy</measure>
    <time_frame>intraoperative period</time_frame>
    <description>Pulmonary embolism&#xD;
Clinical suspicious:Systolic blood pressure &lt; 90 mmHg without other reasonable causes, partial pressure of oxygen in artery &lt; 80 mmHg&#xD;
Confirmed diagnosis: intraoperative TEE (direct demonstration of PE or indirect signs of PE), CT angiography, perfusion lung scan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of postoperative PE of renal cancer patient undergoing nephrectomy</measure>
    <time_frame>until 7 days after surgery</time_frame>
    <description>Pulmonary embolism&#xD;
Clinical suspicious:Systolic blood pressure &lt; 90 mmHg without other reasonable causes, partial pressure of oxygen in artery &lt; 80 mmHg&#xD;
Confirmed diagnosis: intraoperative TEE (direct demonstration of PE or indirect signs of PE), CT angiography, perfusion lung scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>7 days after surgery</time_frame>
    <description>Hospital stay&#xD;
ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with postoperative organ dysfunction</measure>
    <time_frame>7 days after surgery</time_frame>
    <description>Organ dysfunction&#xD;
acute kidney injury&#xD;
acute respiratory distress syndrome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of TEE utilization</measure>
    <time_frame>7 days after surgery</time_frame>
    <description>TEE utilization&#xD;
for monitoring (use when the case begins)&#xD;
for rescue (use when unexplained hypotension or hemodynamic collapsed)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate at 30 days postoperative</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Patients death after surgery</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">416</enrollment>
  <condition>Pulmonary Embolism</condition>
  <condition>Renal Cell Carcinoma</condition>
  <condition>Nephrectomy</condition>
  <arm_group>
    <arm_group_label>Nephrectomy</arm_group_label>
    <description>Patients underwent nephrectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nephrectomy</intervention_name>
    <description>Patients underwent nephrectomy</description>
    <arm_group_label>Nephrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Every adult patients with renal carcinoma underwent nephrectomy will be recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with renal cancer undergoing nephrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with incomplete data&#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>Aphichat Suphathamwit, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine Siriraj Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <citation>Desciak MC, Martin DE. Perioperative pulmonary embolism: diagnosis and anesthetic management. J Clin Anesth. 2011 Mar;23(2):153-65. doi: 10.1016/j.jclinane.2010.06.011.</citation>
    <PMID>21377083</PMID>
  </reference>
  <results_reference>
    <citation>Cisek LJ, Walsh PC. Thromboembolic complications following radical retropubic prostatectomy. Influence of external sequential pneumatic compression devices. Urology. 1993 Oct;42(4):406-8. doi: 10.1016/0090-4295(93)90369-l.</citation>
    <PMID>8212439</PMID>
  </results_reference>
  <results_reference>
    <citation>Pettus JA, Eggener SE, Shabsigh A, Yanke B, Snyder ME, Serio A, Vickers A, Russo P, Donat SM. Perioperative clinical thromboembolic events after radical or partial nephrectomy. Urology. 2006 Nov;68(5):988-92. doi: 10.1016/j.urology.2006.06.026.</citation>
    <PMID>17113889</PMID>
  </results_reference>
  <results_reference>
    <citation>Fukazawa K, Fong CT, Gologorsky E. Inferior Vena Cava Tumor Thrombus Dynamics and Perioperative Pulmonary Embolism: A Single-Center Experience. J Cardiothorac Vasc Anesth. 2019 Oct;33(10):2728-2734. doi: 10.1053/j.jvca.2019.03.011. Epub 2019 Mar 15.</citation>
    <PMID>31072702</PMID>
  </results_reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 7, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04402749
org study id: 2020_2
nct id: NCT04402749
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with renal carcinoma was reported at high incidence of perioperative pulmonary
      embolism from current study. The investigators aimed to determine the incidence and outcome
      of this group of patient in the tertiary-care, university hospital and the rate of
      intraoperative transesophageal echocardiography utility and outcome.
Perioperative pulmonary embolism (PE) is the serious adverse event leading to major morbidity
      and mortality. The incidence of PE during urologic surgery was previously report at 0.9 -
      1.1% with mortality rate less than 2%. But the recent study by Fukazawa et al report the
      incidence of PE was 11% in renal cancer patients underwent nephrectomy with mortality rate as
      high as 33%. The risk factors associated with PE included major surgery, cancer, arrhythmia,
      massive bleeding and level of tumor thrombus in inferior vena cava.

      Transesophageal echocardiography (TEE) is a very helpful intraoperative monitoring tool in
      major, non-cardiac surgery to detect emboli and guide the hemodynamic management in severely
      unstable patients. But it requires sophisticate machine and well-trained operator, the rate
      of utilisation was still limited.

      The investigators aimed to determine the incidence of perioperative PE in renal cancer
      patients undergoing nephrectomy. the secondary outcomes include risk factors associated with
      perioperative PE, clinical outcomes, the rate of TEE utilization in this operation and
      outcome.
observational model: Other
time perspective: Retrospective
measure: The incidence of intraoperative PE of renal cancer patient undergoing nephrectomy
time frame: intraoperative period
description: Pulmonary embolism
Clinical suspicious:Systolic blood pressure < 90 mmHg without other reasonable causes, partial pressure of oxygen in artery < 80 mmHg
Confirmed diagnosis: intraoperative TEE (direct demonstration of PE or indirect signs of PE), CT angiography, perfusion lung scan
measure: The incidence of postoperative PE of renal cancer patient undergoing nephrectomy
time frame: until 7 days after surgery
description: Pulmonary embolism
Clinical suspicious:Systolic blood pressure < 90 mmHg without other reasonable causes, partial pressure of oxygen in artery < 80 mmHg
Confirmed diagnosis: intraoperative TEE (direct demonstration of PE or indirect signs of PE), CT angiography, perfusion lung scan
measure: Length of stay
time frame: 7 days after surgery
description: Hospital stay
ICU stay
measure: Number of patients with postoperative organ dysfunction
time frame: 7 days after surgery
description: Organ dysfunction
acute kidney injury
acute respiratory distress syndrome
measure: Rate of TEE utilization
time frame: 7 days after surgery
description: TEE utilization
for monitoring (use when the case begins)
for rescue (use when unexplained hypotension or hemodynamic collapsed)
measure: Mortality rate at 30 days postoperative
time frame: 30 days after surgery
description: Patients death after surgery
arm group label: Nephrectomy
description: Patients underwent nephrectomy
intervention type: Other
intervention name: Nephrectomy
description: Patients underwent nephrectomy
arm group label: Nephrectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aphichat Suphathamwit, M.D.
role: Principal Investigator
affiliation: Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND
facility: 
country: Thailand
citation: Desciak MC, Martin DE. Perioperative pulmonary embolism: diagnosis and anesthetic management. J Clin Anesth. 2011 Mar;23(2):153-65. doi: 10.1016/j.jclinane.2010.06.011.
PMID: 21377083
citation: Cisek LJ, Walsh PC. Thromboembolic complications following radical retropubic prostatectomy. Influence of external sequential pneumatic compression devices. Urology. 1993 Oct;42(4):406-8. doi: 10.1016/0090-4295(93)90369-l.
PMID: 8212439
citation: Pettus JA, Eggener SE, Shabsigh A, Yanke B, Snyder ME, Serio A, Vickers A, Russo P, Donat SM. Perioperative clinical thromboembolic events after radical or partial nephrectomy. Urology. 2006 Nov;68(5):988-92. doi: 10.1016/j.urology.2006.06.026.
PMID: 17113889
citation: Fukazawa K, Fong CT, Gologorsky E. Inferior Vena Cava Tumor Thrombus Dynamics and Perioperative Pulmonary Embolism: A Single-Center Experience. J Cardiothorac Vasc Anesth. 2019 Oct;33(10):2728-2734. doi: 10.1053/j.jvca.2019.03.011. Epub 2019 Mar 15.
PMID: 31072702
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Pulmonary Embolism
mesh term: Embolism
sharing ipd: No