<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/NCT03259594</url>
  </required_header>
  <id_info>
    <org_study_id>otw-20170804-01</org_study_id>
    <nct_id>NCT03259594</nct_id>
  </id_info>
  <brief_title>Measurement of Renal Functional Reserve Change In Patients With SRC Before and After Laparoscopic Deroofing</brief_title>
  <official_title>Measurement of Renal Functional Reserve Change In Patients With Simple Renal Cysts Before and After Laparoscopic Deroofing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ou tongwen</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 improved in patients with simple renal cysts after&#xD;
      laparoscopic deroofing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Simple renal cysts (SRC) are the most frequent type of cystic renal disease. The prevalence&#xD;
      rate of SRCs is about 10% and increases with age. Hypertension and decreased renal functions&#xD;
      have been reported to occur more commonly among these patients with SRC and there are no&#xD;
      clear guidelines for managing asymptomatic SRCs.Renal functional reserve (RFR) describes the&#xD;
      capacity of the intact nephron mass to increase glomerular filtration rate(GFR) from baseline&#xD;
      in response to stimuli (e.g., protein load).The investigators hypothesized that RFR may be&#xD;
      improved in some patients with simple renal cysts after laparoscopic deroofing despite&#xD;
      identical resting glomerular filtration rate (rGFR).The aim of this study is to examine&#xD;
      whether there is improvement of RFR in patients with simple renal cysts after laparoscopic&#xD;
      deroofing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants are assigned to two groups.One group participants are with endophytic simple renal cysts, and the other are with exophytic simple renal cysts.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in renal functional reserve after laparoscopic deroofing</measure>
    <time_frame>1 month after surgery.</time_frame>
    <description>1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Simple Renal Cyst</condition>
  <arm_group>
    <arm_group_label>endophytic group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>participants are with endophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>exophytic group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>participants are with exophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic deroofing</intervention_name>
    <description>The classic treatment of patients with simple renal cysts is deroofing, which can be performed by open surgery or laparoscopy. Laparoscopic deroofing is an effective minimally invasive approach and has gained popularity.</description>
    <arm_group_label>endophytic group</arm_group_label>
    <arm_group_label>exophytic group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>100 g of amino acids supplementation</intervention_name>
    <description>intravenous supplementation with 100 g of amino acids 2 day before laparoscopic deroofing.</description>
    <arm_group_label>endophytic group</arm_group_label>
    <arm_group_label>exophytic group</arm_group_label>
    <other_name>Compound Amino Acids Injection(18AA-Ⅶ)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18&#xD;
&#xD;
          2. Estimated GFR &gt;30 mL/min/1.73m2&#xD;
&#xD;
          3. 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. 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;
          4. Use of medications which directly affect elimination of creatinine (e.g. cimetidine&#xD;
             and trimethoprim)&#xD;
&#xD;
          5. Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months&#xD;
             requiring hospitalization or oral steroid therapy&#xD;
&#xD;
          6. Inadequate intravenous access&#xD;
&#xD;
          7. Severe anemia (Hct &lt;21%)&#xD;
&#xD;
          8. 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;
          9. History of contrast-induced nephropathy&#xD;
&#xD;
         10. Hyperthyroidism&#xD;
&#xD;
         11. Pheochromocytoma&#xD;
&#xD;
         12. Sickle cell disease&#xD;
&#xD;
         13. Urinary retention or incontinence&#xD;
&#xD;
         14. Status post organ transplant&#xD;
&#xD;
         15. Pregnancy or active breast feeding&#xD;
&#xD;
         16. Cognitive impairment with inability to give consent&#xD;
&#xD;
         17. 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, MD.</last_name>
    <phone>+8683198448</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xuanwu Hospital Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhenhua Shang, MD.</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>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Xuanwu Hospital, Beijing</investigator_affiliation>
    <investigator_full_name>ou tongwen</investigator_full_name>
    <investigator_title>Head of Urology</investigator_title>
  </responsible_party>
  <keyword>Renal functional reserve</keyword>
  <keyword>Simple renal cysts</keyword>
  <keyword>Laparoscopic deroofing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cysts</mesh_term>
    <mesh_term>Kidney Diseases, Cystic</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/NCT03259594
org study id: otw-20170804-01
nct id: NCT03259594
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Renal functional reserve may be improved in patients with simple renal cysts after
      laparoscopic deroofing.
Simple renal cysts (SRC) are the most frequent type of cystic renal disease. The prevalence
      rate of SRCs is about 10% and increases with age. Hypertension and decreased renal functions
      have been reported to occur more commonly among these patients with SRC and there are no
      clear guidelines for managing asymptomatic SRCs.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).The investigators hypothesized that RFR may be
      improved in some patients with simple renal cysts after laparoscopic deroofing despite
      identical resting glomerular filtration rate (rGFR).The aim of this study is to examine
      whether there is improvement of RFR in patients with simple renal cysts after laparoscopic
      deroofing.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to two groups.One group participants are with endophytic simple renal cysts, and the other are with exophytic simple renal cysts.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in renal functional reserve after laparoscopic deroofing
time frame: 1 month after surgery.
description: 1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.
arm group label: endophytic group
arm group type: Experimental
description: participants are with endophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
arm group label: exophytic group
arm group type: Sham Comparator
description: participants are with exophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
intervention type: Procedure
intervention name: Laparoscopic deroofing
description: The classic treatment of patients with simple renal cysts is deroofing, which can be performed by open surgery or laparoscopy. Laparoscopic deroofing is an effective minimally invasive approach and has gained popularity.
arm group label: endophytic group
arm group label: exophytic group
intervention type: Drug
intervention name: 100 g of amino acids supplementation
description: intravenous supplementation with 100 g of amino acids 2 day before laparoscopic deroofing.
arm group label: endophytic group
arm group label: exophytic group
other name: Compound Amino Acids Injection(18AA-Ⅶ)
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, MD.
phone: +8683198448
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Xuanwu Hospital, Beijing
investigator full name: ou tongwen
investigator title: Head of Urology
mesh term: Cysts
mesh term: Kidney Diseases, Cystic
sharing ipd: No