<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/NCT04503148</url>
  </required_header>
  <id_info>
    <org_study_id>Ane-Can Nx</org_study_id>
    <nct_id>NCT04503148</nct_id>
  </id_info>
  <brief_title>Anesthesia and Cancer Study: Renal Cell Carcinoma</brief_title>
  <official_title>The Influence of Type of Anesthesia on Recurrence of Renal Cell Carcinoma After Nephrectomy: a Prospective Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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 investigates the influence of type of anesthesia on recurrence and survival of&#xD;
      renal cell carcinoma in patients undergoing nephrectomy. The participants will be allocated&#xD;
      to either the group receiving the total intravenous anesthesia (TIVA) using propofol or the&#xD;
      group receiving the inhaled anesthetics, such as sevoflurane or desflurane.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effect of anesthesia on cancer recurrence and survival is controversial. According to&#xD;
      some retrospective studies and preclinical studies, TIVA is suggested to be more favorable&#xD;
      than inhalation anesthesia regarding cancer recurrence and survival after surgery. However,&#xD;
      to our knowledge, there is no study which investigates the influence of type of anesthesia on&#xD;
      recurrence of renal cell carcinoma after nephrectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 22, 2020</start_date>
  <completion_date type="Anticipated">December 22, 2025</completion_date>
  <primary_completion_date type="Actual">December 22, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A prospective randomized controlled study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>one year metastasis-free survival</measure>
    <time_frame>one years after surgery</time_frame>
    <description>one year metastasis-free survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>three year metastasis-free survival</measure>
    <time_frame>three years after surgery</time_frame>
    <description>three year metastasis-free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>one year survival</measure>
    <time_frame>one year after surgery</time_frame>
    <description>survival rate regardless of recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>three year survival</measure>
    <time_frame>three year after surgery</time_frame>
    <description>survival rate regardless of recurrence</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">562</enrollment>
  <condition>Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>TIVA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the total intravenous anesthesia using propofol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>inhalation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receiving inhalation anesthesia using sevoflurane or desflurane</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia</description>
    <arm_group_label>TIVA group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Inhaled General Anesthetics</intervention_name>
    <description>Sevoflurane or desflurane for induction and maintenance of anesthesia</description>
    <arm_group_label>inhalation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients scheduled for elective nephrectomy due to renal cell carcinoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Allergies to anesthetics&#xD;
&#xD;
          -  Palliative surgery&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
&#xD;
          -  History of diagnosis or surgery for other 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>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin-Tae Kim</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Anesthesia</keyword>
  <keyword>Propofol</keyword>
  <keyword>Inhaled anesthetics</keyword>
  <keyword>Renal cell carcinoma</keyword>
  <keyword>Nephrectomy</keyword>
  <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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Anesthetics, General</mesh_term>
    <mesh_term>Anesthetics, Inhalation</mesh_term>
  </intervention_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/NCT04503148
org study id: Ane-Can Nx
nct id: NCT04503148
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the influence of type of anesthesia on recurrence and survival of
      renal cell carcinoma in patients undergoing nephrectomy. The participants will be allocated
      to either the group receiving the total intravenous anesthesia (TIVA) using propofol or the
      group receiving the inhaled anesthetics, such as sevoflurane or desflurane.
The effect of anesthesia on cancer recurrence and survival is controversial. According to
      some retrospective studies and preclinical studies, TIVA is suggested to be more favorable
      than inhalation anesthesia regarding cancer recurrence and survival after surgery. However,
      to our knowledge, there is no study which investigates the influence of type of anesthesia on
      recurrence of renal cell carcinoma after nephrectomy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective randomized controlled study
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: one year metastasis-free survival
time frame: one years after surgery
description: one year metastasis-free survival
measure: three year metastasis-free survival
time frame: three years after surgery
description: three year metastasis-free survival
measure: one year survival
time frame: one year after surgery
description: survival rate regardless of recurrence
measure: three year survival
time frame: three year after surgery
description: survival rate regardless of recurrence
arm group label: TIVA group
arm group type: Experimental
description: Patients receiving the total intravenous anesthesia using propofol
arm group label: inhalation group
arm group type: Active Comparator
description: Patients receiving inhalation anesthesia using sevoflurane or desflurane
intervention type: Drug
intervention name: Propofol
description: Propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia
arm group label: TIVA group
intervention type: Drug
intervention name: Inhaled General Anesthetics
description: Sevoflurane or desflurane for induction and maintenance of anesthesia
arm group label: inhalation group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin-Tae Kim
investigator title: professor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Propofol
mesh term: Anesthetics
mesh term: Anesthetics, General
mesh term: Anesthetics, Inhalation
sharing ipd: No