<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/NCT01732120</url>
  </required_header>
  <id_info>
    <org_study_id>myIRB ID 201208091</org_study_id>
    <nct_id>NCT01732120</nct_id>
  </id_info>
  <brief_title>Off Clamp Randomization</brief_title>
  <official_title>Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Midwest Stone Institute.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to compare the effects on kidney function after&#xD;
      performing the removal of a kidney tumor with or without clamping the blood vessels during&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change From Baseline in eGFR</measure>
    <time_frame>baseline and 3 months post nephrectomy</time_frame>
    <description>Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Split Renal Function</measure>
    <time_frame>baseline to 3 months post nephrectomy</time_frame>
    <description>Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of Observations With Positive Surgical Margins.</measure>
    <time_frame>at the time of nephrectomy</time_frame>
    <description>Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated Blood Loss</measure>
    <time_frame>At the time of nephrectomy</time_frame>
    <description>Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Observations With Metastasis</measure>
    <time_frame>3 years</time_frame>
    <description>Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative Time Measured in Minutes.</measure>
    <time_frame>At the time of nephrectomy</time_frame>
    <description>Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Warm Ischemia Time Measured in Minutes.</measure>
    <time_frame>At the time of nephrectomy.</time_frame>
    <description>Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Observations With Intra-operative Complications.</measure>
    <time_frame>At the time of nephrectomy</time_frame>
    <description>Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hospital Days Post Nephrectomy.</measure>
    <time_frame>Day of nephrectomy to day of hospital discharge.</time_frame>
    <description>Perioperative outcomes will be assessed based number of hospital days post nephrectomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Observations With Postoperative Complications.</measure>
    <time_frame>Within 3 months post nephrectomy.</time_frame>
    <description>Perioperative outcomes will be assessed based on percent of observations with postoperative complications.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Renal Cancer</condition>
  <condition>Renal Ischemia</condition>
  <arm_group>
    <arm_group_label>Off-clamp partial nephrectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional partial nephrectomy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Off-clamp partial nephrectomy</intervention_name>
    <arm_group_label>Off-clamp partial nephrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 and older.&#xD;
&#xD;
          -  Patients willing and able to sign consent.&#xD;
&#xD;
          -  Patients with an organ confined renal mass planning to undergo a robotic assisted&#xD;
             partial nephrectomy (RAPN).&#xD;
&#xD;
          -  Patient with Karnofsky Performance Status (KPS) equal to or greater than 40.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18.&#xD;
&#xD;
          -  Patients with Karnofsky Performance Status (KPS) less than 40.&#xD;
&#xD;
          -  Patients with non-organ confined renal masses (invading renal vein, inferior vena&#xD;
             cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis).&#xD;
&#xD;
          -  Patients with bilateral synchronous renal masses.&#xD;
&#xD;
          -  Patients who can not discontinue Plavix, Coumadin or other anti-platelet or&#xD;
             anti-coagulant medications.&#xD;
&#xD;
          -  Patients with renal lesions determined to be too complex to perform a RAPN without&#xD;
             clamp by the surgeon. (The renal mass may be deemed too difficult based on&#xD;
             pre-operatively radiological findings. The surgeon's decision to exclude a mass from a&#xD;
             robotic assisted partial nephrectomy would be based on a higher risk of positive&#xD;
             margin or complication if a RAPN was performed.)&#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>Robert S Figenshau, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <results_first_submitted>March 9, 2022</results_first_submitted>
  <results_first_submitted_qc>March 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 9, 2022</results_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>off-clamp</keyword>
  <keyword>partial nephrectomy</keyword>
  <keyword>renal cancer treatment</keyword>
  <keyword>renal ischemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 1, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT01732120/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Off-clamp Partial Nephrectomy</title>
          <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.&#xD;
Off-clamp partial nephrectomy</description>
        </group>
        <group group_id="P2">
          <title>Traditional Partial Nephrectomy</title>
          <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Off-clamp Partial Nephrectomy</title>
          <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.&#xD;
Off-clamp partial nephrectomy</description>
        </group>
        <group group_id="B2">
          <title>Traditional Partial Nephrectomy</title>
          <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.6" spread="9.8"/>
                    <measurement group_id="B2" value="59.4" spread="11.2"/>
                    <measurement group_id="B3" value="58.0" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in eGFR</title>
        <description>Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.</description>
        <time_frame>baseline and 3 months post nephrectomy</time_frame>
        <population>Missing 3 postoperative eGFR from the Traditional Partial Nephrectomy group and 6 from the Off-Clamp Partial Nephrectomy group.</population>
        <group_list>
          <group group_id="O1">
            <title>Off-clamp Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.&#xD;
Off-clamp partial nephrectomy</description>
          </group>
          <group group_id="O2">
            <title>Traditional Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in eGFR</title>
          <description>Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.</description>
          <population>Missing 3 postoperative eGFR from the Traditional Partial Nephrectomy group and 6 from the Off-Clamp Partial Nephrectomy group.</population>
          <units>percent change in eGFR</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.7" lower_limit="-16.1" upper_limit="-5.3"/>
                    <measurement group_id="O2" value="-9.4" lower_limit="-14.0" upper_limit="-4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Split Renal Function</title>
        <description>Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy.</description>
        <time_frame>baseline to 3 months post nephrectomy</time_frame>
        <population>Missing 1 postoperative renal scan from the Traditional Partial Nephrectomy group and 7 from the Off-Clamp Partial Nephrectomy group.</population>
        <group_list>
          <group group_id="O1">
            <title>Off-clamp Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.&#xD;
Off-clamp partial nephrectomy</description>
          </group>
          <group group_id="O2">
            <title>Traditional Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Split Renal Function</title>
          <description>Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy.</description>
          <population>Missing 1 postoperative renal scan from the Traditional Partial Nephrectomy group and 7 from the Off-Clamp Partial Nephrectomy group.</population>
          <units>percent change in split renal function</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.2" lower_limit="-15.9" upper_limit="-6.5"/>
                    <measurement group_id="O2" value="-11.8" lower_limit="-15.9" upper_limit="-7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Observations With Positive Surgical Margins.</title>
        <description>Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins.</description>
        <time_frame>at the time of nephrectomy</time_frame>
        <population>Only malignant cases were included in the analysis of positive margins.</population>
        <group_list>
          <group group_id="O1">
            <title>Off-clamp Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.&#xD;
Off-clamp partial nephrectomy</description>
          </group>
          <group group_id="O2">
            <title>Traditional Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Observations With Positive Surgical Margins.</title>
          <description>Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins.</description>
          <population>Only malignant cases were included in the analysis of positive margins.</population>
          <units>percent of cases with positive margins</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" lower_limit="0.8" upper_limit="20.8"/>
                    <measurement group_id="O2" value="5.9" lower_limit="0.7" upper_limit="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estimated Blood Loss</title>
        <description>Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.</description>
        <time_frame>At the time of nephrectomy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Off-clamp Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.&#xD;
Off-clamp partial nephrectomy</description>
          </group>
          <group group_id="O2">
            <title>Traditional Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated Blood Loss</title>
          <description>Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.</description>
          <units>Milliliters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="184.1" spread="193.3"/>
                    <measurement group_id="O2" value="178.5" spread="207.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Observations With Metastasis</title>
        <description>Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy.</description>
        <time_frame>3 years</time_frame>
        <population>Only malignant cases were included in the analysis of metastasis on follow-up imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>Off-clamp Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.&#xD;
Off-clamp partial nephrectomy</description>
          </group>
          <group group_id="O2">
            <title>Traditional Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Observations With Metastasis</title>
          <description>Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy.</description>
          <population>Only malignant cases were included in the analysis of metastasis on follow-up imaging.</population>
          <units>percent of cases with metastasis on f/u</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="2.9" lower_limit="0.1" upper_limit="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Operative Time Measured in Minutes.</title>
        <description>Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.</description>
        <time_frame>At the time of nephrectomy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Off-clamp Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.&#xD;
Off-clamp partial nephrectomy</description>
          </group>
          <group group_id="O2">
            <title>Traditional Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
          </group>
        </group_list>
        <measure>
          <title>Operative Time Measured in Minutes.</title>
          <description>Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.</description>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="178.0" spread="44.4"/>
                    <measurement group_id="O2" value="156.0" spread="40.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Warm Ischemia Time Measured in Minutes.</title>
        <description>Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy.</description>
        <time_frame>At the time of nephrectomy.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Off-clamp Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.&#xD;
Off-clamp partial nephrectomy</description>
          </group>
          <group group_id="O2">
            <title>Traditional Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
          </group>
        </group_list>
        <measure>
          <title>Warm Ischemia Time Measured in Minutes.</title>
          <description>Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy.</description>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.0"/>
                    <measurement group_id="O2" value="19.1" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Observations With Intra-operative Complications.</title>
        <description>Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy.</description>
        <time_frame>At the time of nephrectomy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Off-clamp Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.&#xD;
Off-clamp partial nephrectomy</description>
          </group>
          <group group_id="O2">
            <title>Traditional Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Observations With Intra-operative Complications.</title>
          <description>Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy.</description>
          <units>% of cases with intraop complications</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="0.1" upper_limit="13.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Hospital Days Post Nephrectomy.</title>
        <description>Perioperative outcomes will be assessed based number of hospital days post nephrectomy.</description>
        <time_frame>Day of nephrectomy to day of hospital discharge.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Off-clamp Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.&#xD;
Off-clamp partial nephrectomy</description>
          </group>
          <group group_id="O2">
            <title>Traditional Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Hospital Days Post Nephrectomy.</title>
          <description>Perioperative outcomes will be assessed based number of hospital days post nephrectomy.</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.9"/>
                    <measurement group_id="O2" value="1.7" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Observations With Postoperative Complications.</title>
        <description>Perioperative outcomes will be assessed based on percent of observations with postoperative complications.</description>
        <time_frame>Within 3 months post nephrectomy.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Off-clamp Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.&#xD;
Off-clamp partial nephrectomy</description>
          </group>
          <group group_id="O2">
            <title>Traditional Partial Nephrectomy</title>
            <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Observations With Postoperative Complications.</title>
          <description>Perioperative outcomes will be assessed based on percent of observations with postoperative complications.</description>
          <units>% of cases with postop complications</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="7.6" upper_limit="32.4"/>
                    <measurement group_id="O2" value="17.5" lower_limit="5.7" upper_limit="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from time of study intervention to the three-month post nephrectomy visit.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Off-clamp Partial Nephrectomy</title>
          <description>Partial nephrectomy will be performed without clamping of the renal blood vessels.&#xD;
Off-clamp partial nephrectomy</description>
        </group>
        <group group_id="E2">
          <title>Traditional Partial Nephrectomy</title>
          <description>Partial nephrectomy will be performed with clamping of the renal blood vessels.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>postoperative bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>pseudoaneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>acute pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>wound dehiscence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Manager of Clinical Trials</name_or_title>
      <organization>Washington University School of Medicine</organization>
      <phone>3147479781</phone>
      <email>klima@wustl.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01732120
org study id: myIRB ID 201208091
nct id: NCT01732120
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this research study is to compare the effects on kidney function after
      performing the removal of a kidney tumor with or without clamping the blood vessels during
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Percent Change From Baseline in eGFR
time frame: baseline and 3 months post nephrectomy
description: Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.
measure: Percent Change From Baseline in Split Renal Function
time frame: baseline to 3 months post nephrectomy
description: Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy.
measure: Percent of Observations With Positive Surgical Margins.
time frame: at the time of nephrectomy
description: Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins.
measure: Estimated Blood Loss
time frame: At the time of nephrectomy
description: Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.
measure: Percent of Observations With Metastasis
time frame: 3 years
description: Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy.
measure: Operative Time Measured in Minutes.
time frame: At the time of nephrectomy
description: Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.
measure: Warm Ischemia Time Measured in Minutes.
time frame: At the time of nephrectomy.
description: Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy.
measure: Percent of Observations With Intra-operative Complications.
time frame: At the time of nephrectomy
description: Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy.
measure: Number of Hospital Days Post Nephrectomy.
time frame: Day of nephrectomy to day of hospital discharge.
description: Perioperative outcomes will be assessed based number of hospital days post nephrectomy.
measure: Percent of Observations With Postoperative Complications.
time frame: Within 3 months post nephrectomy.
description: Perioperative outcomes will be assessed based on percent of observations with postoperative complications.
arm group label: Off-clamp partial nephrectomy
arm group type: Experimental
description: Partial nephrectomy will be performed without clamping of the renal blood vessels.
arm group label: Traditional partial nephrectomy
arm group type: No Intervention
description: Partial nephrectomy will be performed with clamping of the renal blood vessels.
intervention type: Procedure
intervention name: Off-clamp partial nephrectomy
arm group label: Off-clamp partial nephrectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert S Figenshau, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Neoplasms
mesh term: Carcinoma, Renal Cell
mesh term: Ischemia
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 