<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/NCT01720693</url>
  </required_header>
  <id_info>
    <org_study_id>Hypoperfusion</org_study_id>
    <nct_id>NCT01720693</nct_id>
  </id_info>
  <brief_title>Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy</brief_title>
  <official_title>A Pilot Study to Examine a Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many patients who are candidates for nephron-sparing surgery, partial nephrectomy is now the&#xD;
      standard treatment with a surgical, small, clinical T1 tumor (&lt;7 cm). In many recent studies,&#xD;
      partial nephrectomy provides equivalent oncologic, and superior functional, outcomes compared&#xD;
      with the standard radical nephrectomy over the short and long term (2, 3). Partial&#xD;
      nephrectomy techniques, whether open, laparoscopic or robotic, typically involve hilar&#xD;
      clamping, which creates the desired bloodless operative field, allowing for more precise&#xD;
      tumor excision and renal reconstruction. This hilar clamping eventually may lead to ischemic&#xD;
      kidney injury which can compromise the functional outcomes of the remaining kidney.We are&#xD;
      working now to develop a novel technique of Hypo-Perfusion by achieving partial renal&#xD;
      arterial clamping, with the goal of completely eliminating surgical ischemia to the renal&#xD;
      remnant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low accrual&#xD;
  </why_stopped>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To perfect the Renal Hypoperfusion during partial nephrectomy is feasible safe and result in better renal function than complete occlusion of renal blood flow</measure>
    <time_frame>up to 2 weeks prior to surgery and up to 24 hrs post surgery</time_frame>
    <description>renal function will be measured using creatinine, eGFR, 24 hr creat clearance, and NGAL biomarker of acute kidney injury</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Partial Nephrectomy</condition>
  <condition>Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>hypoperfusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hypoperfusion of the renal artery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hypoperfusion of renal artery</intervention_name>
    <description>The renal artery is occluded to 30% of it's baseline, prior to kidney tumour removal</description>
    <arm_group_label>hypoperfusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must be at least 18 years old scheduled for open partial nephrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No prior diagnosis of renal artery disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Jewett, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>February 10, 2015</last_update_submitted>
  <last_update_submitted_qc>February 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>partial nephrectomy</keyword>
  <keyword>hypoperfusion</keyword>
  <keyword>renal function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <!-- 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/NCT01720693
org study id: Hypoperfusion
nct id: NCT01720693
lead sponsor: 
has dmc: No
Many patients who are candidates for nephron-sparing surgery, partial nephrectomy is now the
      standard treatment with a surgical, small, clinical T1 tumor (<7 cm). In many recent studies,
      partial nephrectomy provides equivalent oncologic, and superior functional, outcomes compared
      with the standard radical nephrectomy over the short and long term (2, 3). Partial
      nephrectomy techniques, whether open, laparoscopic or robotic, typically involve hilar
      clamping, which creates the desired bloodless operative field, allowing for more precise
      tumor excision and renal reconstruction. This hilar clamping eventually may lead to ischemic
      kidney injury which can compromise the functional outcomes of the remaining kidney.We are
      working now to develop a novel technique of Hypo-Perfusion by achieving partial renal
      arterial clamping, with the goal of completely eliminating surgical ischemia to the renal
      remnant.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: To perfect the Renal Hypoperfusion during partial nephrectomy is feasible safe and result in better renal function than complete occlusion of renal blood flow
time frame: up to 2 weeks prior to surgery and up to 24 hrs post surgery
description: renal function will be measured using creatinine, eGFR, 24 hr creat clearance, and NGAL biomarker of acute kidney injury
arm group label: hypoperfusion
arm group type: Experimental
description: Hypoperfusion of the renal artery
intervention type: Procedure
intervention name: Hypoperfusion of renal artery
description: The renal artery is occluded to 30% of it's baseline, prior to kidney tumour removal
arm group label: hypoperfusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Michael Jewett, M.D.
role: Principal Investigator
affiliation: University Health Network, Toronto
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Carcinoma, Renal Cell