<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/NCT03259477</url>
  </required_header>
  <id_info>
    <org_study_id>otw-20170804-02</org_study_id>
    <nct_id>NCT03259477</nct_id>
  </id_info>
  <brief_title>RFR Change of Precise Segmental Versus Complete Renal Arterial Clamping During LPN for Clinical T1 RCC</brief_title>
  <official_title>Renal Functional Reserve Change of Precise Segmental Versus Complete Renal Arterial Clamping During Laparoscopic Partial Nephrectomy for Clinical T1 Renal Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xuanwu Hospital, Beijing</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>
      Renal functional reserve may be better in patients with clinical T1 renal cell carcinoma(RCC)&#xD;
      undergoing laparoscopic partial nephrectomy with precise segmental renal artery clamping than&#xD;
      those with complete renal arterial clamping.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase&#xD;
      glomerular filtration rate(GFR) from baseline in response to stimuli (e.g., protein load).We&#xD;
      hypothesized that renal functional reserve may be better in patients with clinical T1 renal&#xD;
      cell carcinoma(RCC) undergoing laparoscopic partial(LPN) nephrectomy with precise segmental&#xD;
      renal artery clamping than those with complete renal arterial clamping.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</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>Some participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental during laparoscopic partial nephrectomy and the others undergo complete renal arterial clamping.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Renal Functional Reserve change</measure>
    <time_frame>3 month after surgery.</time_frame>
    <description>Change in renal functional reserve after laparoscopic partial nephrectomy</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>precise segmental clamping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental renal arterial clamping during laparoscopic partial nephrectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>complete clamping</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These participants with clinical T1 renal cell carcinoma(RCC) undergo complete renal arterial clamping during laparoscopic partial nephrectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>precise segmental renal arterial clamping</intervention_name>
    <description>Precise segmental renal artery clamping eliminates global renal ischemia by performing highly selective clamping of single or multiple segmental arteries.</description>
    <arm_group_label>precise segmental clamping</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic partial nephrectomy</intervention_name>
    <description>Laparoscopic partial nephrectomy (LPN) has been widely adopted as a minimally invasive nephron-sparing surgery for clinical T1 renal cell carcinoma(RCC).</description>
    <arm_group_label>complete clamping</arm_group_label>
    <arm_group_label>precise segmental clamping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.Age ≥18 2.Estimated GFR &gt;30 mL/min/1.73m2 3.Anticipated intraoperative warm ischemic&#xD;
             time ≤30 min 4.Subjects who signed informed consent forms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergy to iothalamate, shellfish or iodine&#xD;
&#xD;
          2. Use of metformin or amiodarone&#xD;
&#xD;
          3. intraoperative warm ischemic time &gt;30 min&#xD;
&#xD;
          4. Inability to maintain a stable regimen of medications which affect GFR for &gt; one week&#xD;
             prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin&#xD;
             converting enzyme inhibitors, angiotensin receptor blockers)&#xD;
&#xD;
          5. Use of medications which directly affect elimination of creatinine (e.g. cimetidine&#xD;
             and trimethoprim)&#xD;
&#xD;
          6. Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months&#xD;
             requiring hospitalization or oral steroid therapy&#xD;
&#xD;
          7. Inadequate intravenous access&#xD;
&#xD;
          8. Severe anemia (Hct &lt;21%)&#xD;
&#xD;
          9. Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥&#xD;
             0.3 mg/dL on most recent labs prior to enrollment)&#xD;
&#xD;
         10. History of contrast-induced nephropathy&#xD;
&#xD;
         11. Hyperthyroidism&#xD;
&#xD;
         12. Pheochromocytoma&#xD;
&#xD;
         13. Sickle cell disease&#xD;
&#xD;
         14. Urinary retention or incontinence&#xD;
&#xD;
         15. Status post organ transplant&#xD;
&#xD;
         16. Pregnancy or active breast feeding&#xD;
&#xD;
         17. Cognitive impairment with inability to give consent&#xD;
&#xD;
         18. Institutionalized status&#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>Tongwen Ou, MD.</last_name>
    <role>Study Chair</role>
    <affiliation>Xuanwu Hospital, Beijing</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhenhua Shang, MD.</last_name>
    <phone>+8617801117318</phone>
    <email>shangzhenhua16@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hao Yan</last_name>
    <phone>+8683198448</phone>
    <email>outongwen1967@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xuanwu Hospital Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhenhua Shang</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>April 27, 2020</last_update_submitted>
  <last_update_submitted_qc>April 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xuanwu Hospital, Beijing</investigator_affiliation>
    <investigator_full_name>ou tongwen</investigator_full_name>
    <investigator_title>chairman of urology</investigator_title>
  </responsible_party>
  <keyword>laparoscopic partial nephrectomy</keyword>
  <keyword>precise segmental renal arterial clamping</keyword>
  <keyword>renal cell carcinoma</keyword>
  <keyword>renal functional reserve</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>
  <!-- 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/NCT03259477
org study id: otw-20170804-02
nct id: NCT03259477
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Renal functional reserve may be better in patients with clinical T1 renal cell carcinoma(RCC)
      undergoing laparoscopic partial nephrectomy with precise segmental renal artery clamping than
      those with complete renal arterial clamping.
Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase
      glomerular filtration rate(GFR) from baseline in response to stimuli (e.g., protein load).We
      hypothesized that renal functional reserve may be better in patients with clinical T1 renal
      cell carcinoma(RCC) undergoing laparoscopic partial(LPN) nephrectomy with precise segmental
      renal artery clamping than those with complete renal arterial clamping.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Some participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental during laparoscopic partial nephrectomy and the others undergo complete renal arterial clamping.
primary purpose: Prevention
masking: None (Open Label)
measure: Renal Functional Reserve change
time frame: 3 month after surgery.
description: Change in renal functional reserve after laparoscopic partial nephrectomy
arm group label: precise segmental clamping
arm group type: Experimental
description: These participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental renal arterial clamping during laparoscopic partial nephrectomy.
arm group label: complete clamping
arm group type: Active Comparator
description: These participants with clinical T1 renal cell carcinoma(RCC) undergo complete renal arterial clamping during laparoscopic partial nephrectomy.
intervention type: Procedure
intervention name: precise segmental renal arterial clamping
description: Precise segmental renal artery clamping eliminates global renal ischemia by performing highly selective clamping of single or multiple segmental arteries.
arm group label: precise segmental clamping
intervention type: Procedure
intervention name: laparoscopic partial nephrectomy
description: Laparoscopic partial nephrectomy (LPN) has been widely adopted as a minimally invasive nephron-sparing surgery for clinical T1 renal cell carcinoma(RCC).
arm group label: complete clamping
arm group label: precise segmental clamping
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Tongwen Ou, MD.
role: Study Chair
affiliation: Xuanwu Hospital, Beijing
last name: Zhenhua Shang, MD.
phone: +8617801117318
email: shangzhenhua16@126.com
last name: Hao Yan
phone: +8683198448
email: outongwen1967@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xuanwu Hospital, Beijing
investigator full name: ou tongwen
investigator title: chairman of urology
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell