<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/NCT03822338</url>
  </required_header>
  <id_info>
    <org_study_id>NFH20180205</org_study_id>
    <nct_id>NCT03822338</nct_id>
  </id_info>
  <brief_title>Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy</brief_title>
  <official_title>Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy: a Double-blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing First Hospital, Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing First Hospital, Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The present study is designed to investigate the short-term and long-term renoprotective role&#xD;
      of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Renal ischemia reperfusion injury (IRI) is an inevitable event in patients undergoing&#xD;
      laparoscopic partial nephrectomy (LPN), which can obviously affect the post-operational renal&#xD;
      function. Pneumoperitoneum preconditioning (PP) is a promising strategy to render a&#xD;
      protective effect on kidney, which has been already confirmed in some clinical settings. This&#xD;
      study is designed as a randomized, prospective, double-blind and parallel controlled clinical&#xD;
      trial to assess the short-term and long-term renoprotective role of pneumoperitoneum&#xD;
      preconditioning in patients undergoing laparoscopic partial nephrectomy, and observe its&#xD;
      effect on the other abdominal organs. Patients with renal tunours and willing to accept&#xD;
      elective LPN will be screened as eligible participants. The investigators aim to enroll 86&#xD;
      subjects. Patients randomized to the treatment arm will receive PP consisted of three cycles&#xD;
      of 5 min insufﬂation and 5 min desufﬂation before PLN, while the control arm receive a sham&#xD;
      operation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The absolute change in glomerular filtration rate (GFR)</measure>
    <time_frame>changes from baseline and postoperative 1, 6 months</time_frame>
    <description>Unilateral and overall GFR detected by 99mTc-DTPA renal scintigraphy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The absolute change in the level of serum Cystatin C (Cys C)</measure>
    <time_frame>changes from baseline and 12, 24, 48 hours after desufflation</time_frame>
    <description>The absolute change in the level of serum Cys C after desufflation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The level of serum creatinine (SCr)</measure>
    <time_frame>Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation</time_frame>
    <description>The absolute change in the level of serum SCr after desufflation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated glomerular filtration rate (eGFR)</measure>
    <time_frame>Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation</time_frame>
    <description>eGFR will be calculated by a combined formula.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of alanine transaminase (ALT)</measure>
    <time_frame>Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation</time_frame>
    <description>Serum markers for detecting the insults of the liver.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of serum amylase</measure>
    <time_frame>Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation</time_frame>
    <description>Serum markers for detecting the insults of the pancreas.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of intestinal fatty acid binding protein (I-FABP)</measure>
    <time_frame>Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation</time_frame>
    <description>Serum markers for detecting the insults of the intestine.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Duration of postoperative hospital stay</measure>
    <time_frame>6 months following surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>6 months following surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Rate of mortality</measure>
    <time_frame>6 months following surgery</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Ischemia Reperfusion Injury</condition>
  <arm_group>
    <arm_group_label>Pneumoperitoneum preconditioning group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant assigned to the this group will receive a treatment consisting of three cycles of 5 min insufflation (intra-abdominal pressure at 15 mmHg) and 5 min desufflation, after complete anesthesia and successfully implanting the veress.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants in the control group will receive the same placement of the veress but without insufﬂation and subsequent desufﬂation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pneumoperitoneum preconditioning</intervention_name>
    <description>Pneumoperitoneum preconditioning consists of three cycles of 5 min insufflation and 5 min desufflation, after complete anesthesia and successfully implanting the veress. This process will be induced by pneumoperitoneum machine, and the utilized gas will be carbon dioxide to maintain the intra-abdominal pressure at 15 mmHg. The whole duration will last 30 min.</description>
    <arm_group_label>Pneumoperitoneum preconditioning group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham-Pneumoperitoneum preconditioning</intervention_name>
    <description>Sham-Pneumoperitoneum preconditioning consists of three cycles without insufﬂation and subsequent desufﬂation. The whole duration will also last 30 min.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients aged 18 years and older;&#xD;
&#xD;
          -  Patients with renal tumours (whether benign or malignant) and accept laparoscopic&#xD;
             partial nephrectomy as the surgical method;&#xD;
&#xD;
          -  The renal tumor must be stage T1a (assessed by MRI/CT), and tumor≤4cm in diameter;&#xD;
&#xD;
          -  Unilateral renal tumour, and another contralateral renal function reveal normal (renal&#xD;
             function &gt;40% as determined by radionuclide scintigraphy);&#xD;
&#xD;
          -  Patients volunteer for this study and provided written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Large tumour (tumor&gt;4cm in diameter);&#xD;
&#xD;
          -  Severe renal insufficiency (glomerular filtration rate, GFR&lt;30 ml/min/1.73m2) or&#xD;
             needing preoperative dialysis (hemodialysis or peritoneal dialysis);&#xD;
&#xD;
          -  Patients severe cardiopulmonary dysfunction;&#xD;
&#xD;
          -  Pregnancy Women;&#xD;
&#xD;
          -  Patients with other malignant tumours;&#xD;
&#xD;
          -  Patients who have had a renal transplantation;&#xD;
&#xD;
          -  Patients with a history of other abdominal viscera operations within one year (open or&#xD;
             under laparoscope);&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA)&gt;Ⅲ.&#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_contact>
    <last_name>Ruipeng Jia, MD, PHD</last_name>
    <phone>+86-02552271061</phone>
    <email>urojiarp@njmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Changcheng Zhou, MD</last_name>
    <phone>+86-02552271048</phone>
    <email>zhoucc@njmu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nanjing First Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruipeng Jia, MD, PHD</last_name>
      <phone>+86-02552271061</phone>
      <email>urojiarp@njmu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Ruipeng Jia, MD, PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luwei Xu, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>September 30, 2022</last_update_submitted>
  <last_update_submitted_qc>September 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing First Hospital, Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Ruipeng Jia</investigator_full_name>
    <investigator_title>Study Chair</investigator_title>
  </responsible_party>
  <keyword>Renal ischemia reperfusion injury</keyword>
  <keyword>Pneumoperitoneum preconditioning</keyword>
  <keyword>Laparoscopic partial nephrectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumoperitoneum</mesh_term>
    <mesh_term>Reperfusion Injury</mesh_term>
    <mesh_term>Ischemia</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/NCT03822338
org study id: NFH20180205
nct id: NCT03822338
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study is designed to investigate the short-term and long-term renoprotective role
      of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy.
Renal ischemia reperfusion injury (IRI) is an inevitable event in patients undergoing
      laparoscopic partial nephrectomy (LPN), which can obviously affect the post-operational renal
      function. Pneumoperitoneum preconditioning (PP) is a promising strategy to render a
      protective effect on kidney, which has been already confirmed in some clinical settings. This
      study is designed as a randomized, prospective, double-blind and parallel controlled clinical
      trial to assess the short-term and long-term renoprotective role of pneumoperitoneum
      preconditioning in patients undergoing laparoscopic partial nephrectomy, and observe its
      effect on the other abdominal organs. Patients with renal tunours and willing to accept
      elective LPN will be screened as eligible participants. The investigators aim to enroll 86
      subjects. Patients randomized to the treatment arm will receive PP consisted of three cycles
      of 5 min insufﬂation and 5 min desufﬂation before PLN, while the control arm receive a sham
      operation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The absolute change in glomerular filtration rate (GFR)
time frame: changes from baseline and postoperative 1, 6 months
description: Unilateral and overall GFR detected by 99mTc-DTPA renal scintigraphy.
measure: The absolute change in the level of serum Cystatin C (Cys C)
time frame: changes from baseline and 12, 24, 48 hours after desufflation
description: The absolute change in the level of serum Cys C after desufflation.
measure: The level of serum creatinine (SCr)
time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
description: The absolute change in the level of serum SCr after desufflation.
measure: Estimated glomerular filtration rate (eGFR)
time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
description: eGFR will be calculated by a combined formula.
measure: The level of alanine transaminase (ALT)
time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
description: Serum markers for detecting the insults of the liver.
measure: The level of serum amylase
time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
description: Serum markers for detecting the insults of the pancreas.
measure: The level of intestinal fatty acid binding protein (I-FABP)
time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
description: Serum markers for detecting the insults of the intestine.
measure: Duration of postoperative hospital stay
time frame: 6 months following surgery
measure: Incidence of adverse events
time frame: 6 months following surgery
measure: Rate of mortality
time frame: 6 months following surgery
arm group label: Pneumoperitoneum preconditioning group
arm group type: Experimental
description: Participant assigned to the this group will receive a treatment consisting of three cycles of 5 min insufflation (intra-abdominal pressure at 15 mmHg) and 5 min desufflation, after complete anesthesia and successfully implanting the veress.
arm group label: Control group
arm group type: Sham Comparator
description: Participants in the control group will receive the same placement of the veress but without insufﬂation and subsequent desufﬂation.
intervention type: Procedure
intervention name: Pneumoperitoneum preconditioning
description: Pneumoperitoneum preconditioning consists of three cycles of 5 min insufflation and 5 min desufflation, after complete anesthesia and successfully implanting the veress. This process will be induced by pneumoperitoneum machine, and the utilized gas will be carbon dioxide to maintain the intra-abdominal pressure at 15 mmHg. The whole duration will last 30 min.
arm group label: Pneumoperitoneum preconditioning group
intervention type: Procedure
intervention name: Sham-Pneumoperitoneum preconditioning
description: Sham-Pneumoperitoneum preconditioning consists of three cycles without insufﬂation and subsequent desufﬂation. The whole duration will also last 30 min.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ruipeng Jia, MD, PHD
phone: +86-02552271061
email: urojiarp@njmu.edu.cn
last name: Changcheng Zhou, MD
phone: +86-02552271048
email: zhoucc@njmu.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing First Hospital, Nanjing Medical University
investigator full name: Ruipeng Jia
investigator title: Study Chair
mesh term: Pneumoperitoneum
mesh term: Reperfusion Injury
mesh term: Ischemia
sharing ipd: No