<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/NCT03771365</url>
  </required_header>
  <id_info>
    <org_study_id>1stAHGZMU</org_study_id>
    <nct_id>NCT03771365</nct_id>
  </id_info>
  <brief_title>Standard-PCNL vs Mini-PCNL vs Super-mini PCNL for the Treatment of ≥2 cm Renal Stone</brief_title>
  <official_title>An International Multi-center Prospective Cohort Study Comparing the Safety and Efficacy of Super-mini-PCNL, Mini-PCNL and Standard PCNL in the Treatment of ≥2cm Renal Stones</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Military Medical Academy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital de Clinicas José de San Martín</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Goldstadt Private Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College London Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital de Base do Distrito Federal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mexican National Council of Urology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vancouver General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lions Kidney Hospital and Urology Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mt. Carmel Diocesan General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinical Emergency County Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Belgrade</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital das Clínicas, University of Sao Paulo Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vayodha and Venus International Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital of Vinalopo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sismanoglio General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New Mowasat Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The First Affiliated Hospital of Guangzhou Medical University</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>
      Background: Standard-PCNL was considered as the first choice for ≥2 cm renal stones.&#xD;
      Miniaturized technique Mini-PCNL has also been implicated in the past two decades. Recently,&#xD;
      Super-mini PCNL (SMP) was introduced to treated ≤2.5cm renal stone. The miniaturized&#xD;
      techniques seemed to take a longer operating time and have risk of getting infectious&#xD;
      complications. However, there is no high quality of evidence showing that which kind of PCNL&#xD;
      is best or what kind of patients is suitable for standard-PCNL, mini-PCNL or SMP.&#xD;
&#xD;
      Objective: To compare the efficacy and safety of Standard-PCNL (≥24Fr), Mini-PCNL (12-20Fr)&#xD;
      and SMP(10-14Fr) for the treatment of ≥2 cm renal stones Study design: This study is a&#xD;
      prospective, observational, international, multicenter registry cohort study Study&#xD;
      population: All patients ≥14 years with ≥2 cm renal stone who are planned for Standard-PCNL,&#xD;
      Mini-PCNL or SMP are eligible for this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND AND RATIONALE Percutaneous nephrolithotomy (PCNL) is the first-choice for the&#xD;
      treatment of renal stone ≥20 mm with high stone free rate (SFR). However, there are some&#xD;
      sever complications such as bleeding. Severe bleeding needs arterial embolization, which&#xD;
      might impair the renal function. The size of percutaneous access tract has been proven to be&#xD;
      closely related to the risk of bleeding complications. Mini-PCNL was firstly introduced by&#xD;
      Jackman in 1998 to treat pediatric renal stone with the aim to lower the morbidity. Mini-PCNL&#xD;
      was gradually applied to adults. In recent years, urologists were still attempting to reduce&#xD;
      size of the sheath and modify the sheath. They aimed to reduce the risk of bleeding. The&#xD;
      first generation SMP consists of a 10-14 F access sheath with a suction-evacuation function&#xD;
      and a 7-F nephroscope with enhanced irrigation was introduced by Guohua Zeng's group in 2014.&#xD;
      In 2016, Guohua Zeng's group continued to introduce a modified SMP technique and system. The&#xD;
      most remarkable feature of the new generation super-mini percutaneous nephrolithotomy&#xD;
      (New-SMP) was metal irrigation-suction sheath which made the new system have higher&#xD;
      efficiency than the old one. With the modified SMP technique and system, SMP was performed to&#xD;
      treat large renal stone. (≥2cm). Moreover, SMP with an irrigation-suction sheath obviously&#xD;
      improved the efficiency of removing the fragments and lower the intrapelvic pressure.&#xD;
&#xD;
      Although miniaturized techniques decreased the bleeding-related morbidity and have a similar&#xD;
      SFR, they seemed to take a longer operating time and have risk of getting infectious&#xD;
      complications. However, till now, no high quality of evidence demonstrated that what size of&#xD;
      tract is the best for the treatment of ≥2 cm renal stone. Perhaps the investigators should&#xD;
      find out a subgroup suitable for standard-PCNL, Mini-PCNL or SMP respectively.&#xD;
&#xD;
      STUDY OBJECTIVES The aim of this registry is to review current clinical practice on PCNL for&#xD;
      stone treatment. The investigators will explore the answers to the following questions: What&#xD;
      kind of PCNL urologists prefers to used? Is there a best cutoff based on the size of stones&#xD;
      to divide the patients into subgroups, or a scoring system to decide which kind of PCNL is&#xD;
      the best choice for individuals? Primary Objective To compare the stone free rate (SFR) (%)&#xD;
      among standard-PCNL, Mini-PCNL and SMP for the treatment of ≥2 cm renal stone.&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
        1. Bleeding complication: hematocrit drop (g/L) and rate of transfusion (%).&#xD;
&#xD;
        2. Infectious complication: rate of getting fever (≥38℃) (%) and urosepsis (%).&#xD;
&#xD;
        3. Intraoperative indexes: operating time (mins), rate of tubeless/total tubeless (%).&#xD;
&#xD;
        4. Postoperative indexes: hospital stay (mins), visual analogue scale (VAS) score (range&#xD;
           from 0-10, the higher value represents the worse outcome) STUDY DESIGN This study is a&#xD;
           prospective, observational, international, multicenter registry cohort study SELECTION&#xD;
           AND ENROLLMENT OF PARTICIPANTS Clinical Recruitment All sites for this pilot study are&#xD;
           recruited by IAU Members. Each participating center should obtain ethical approval, as&#xD;
           needed, according to local regulations.&#xD;
&#xD;
      Each participating centre will include all consecutive eligible patients. PCNL procedures are&#xD;
      performed according local protocols and surgeons' own propensity. Data will be collected in&#xD;
      the IAU online platform (http://47.74.212.47/#/login), which is developed by IAU. Each&#xD;
      participating center has own account and password to login and collect data. Data analysis&#xD;
      will be coordinated by IAU.&#xD;
&#xD;
      Study Population All patients ≥14 years with ≥2 cm renal stone who are planned for&#xD;
      Standard-PCNL, Mini-PCNL or SMP are eligible for this study.&#xD;
&#xD;
      Surgical procedure The procedure of SMP, mini-PCNL and Standard-PCNL was according to&#xD;
      surgeons' propensity, the related details were recorded online.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Stone free rate (SFR) (%)</measure>
    <time_frame>1-3 months after the day of DJ stent/ureteral catheter removal or the day of operation (if no DJ stent or ureteral catheter placed postoperatively).</time_frame>
    <description>Stone free rate (SFR) (%) are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the kidney which were defined as ≦ 4mm, asymptomatic, non-obstructive and non-infectious stone particles.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perioperative complications</measure>
    <time_frame>intraoperatively or ≤ 1 month postoperatively</time_frame>
    <description>Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively, including intraoperative bleeding, postoperative pain and so on</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Stone, Kidney</condition>
  <condition>Lithiasis Renal</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Standard-PCNL</arm_group_label>
    <description>Perform PCNL with ≥24 Fr access tract for the treatment of ≥2 renal stones</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mini-PCNL</arm_group_label>
    <description>Perform PCNL with 12-20 Fr access tract for the treatment of ≥2 renal stones</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Super-mini PCNL</arm_group_label>
    <description>Perform SMP for the treatment of ≥2 renal stones</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard-PCNL</intervention_name>
    <description>percutaneous nephrostolithotomy (PCNL) with ≥24 Fr access tract for the treatment of ≥2 cm renal stone</description>
    <arm_group_label>Standard-PCNL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mini-PCNL</intervention_name>
    <description>percutaneous nephrostolithotomy (PCNL) with 12-20 Fr access tract for the treatment of ≥2 cm renal stone</description>
    <arm_group_label>Mini-PCNL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SMP</intervention_name>
    <description>percutaneous nephrostolithotomy (PCNL) with 10-14 Fr access tract for the treatment of ≥2 cm renal stone</description>
    <arm_group_label>Super-mini PCNL</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients ≥14 years with ≥2 cm renal stone who are planned for Standard-PCNL, Mini-PCNL&#xD;
        or SMP are eligible for this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient ≥14 years old&#xD;
&#xD;
          -  Patient is a candidate for Standard-PCNL, Mini-PCNL or SMP treatment of a renal stone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient &lt;14 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guohua Zeng, PH.D &amp; MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Guangzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guohua Zeng, PH.D &amp; MD</last_name>
    <phone>+86 13802916676</phone>
    <email>gzgyzgh@vip.sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chao Cai, PH.D &amp; MD</last_name>
    <phone>+86 13512780911</phone>
    <email>673059209@qq.com</email>
  </overall_contact_backup>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 7, 2018</last_update_submitted>
  <last_update_submitted_qc>December 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Guangzhou Medical University</investigator_affiliation>
    <investigator_full_name>Guohua Zeng</investigator_full_name>
    <investigator_title>Vice president</investigator_title>
  </responsible_party>
  <keyword>percutaneous nephrostolithotomy</keyword>
  <keyword>renal stone</keyword>
  <keyword>safety</keyword>
  <keyword>efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Calculi</mesh_term>
    <mesh_term>Lithiasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>It is a international multi-center prospective cohort study, the data is not available to other researchers before the agreement from all the centers</ipd_description>
  </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/NCT03771365
org study id: 1stAHGZMU
nct id: NCT03771365
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Standard-PCNL was considered as the first choice for ≥2 cm renal stones.
      Miniaturized technique Mini-PCNL has also been implicated in the past two decades. Recently,
      Super-mini PCNL (SMP) was introduced to treated ≤2.5cm renal stone. The miniaturized
      techniques seemed to take a longer operating time and have risk of getting infectious
      complications. However, there is no high quality of evidence showing that which kind of PCNL
      is best or what kind of patients is suitable for standard-PCNL, mini-PCNL or SMP.

      Objective: To compare the efficacy and safety of Standard-PCNL (≥24Fr), Mini-PCNL (12-20Fr)
      and SMP(10-14Fr) for the treatment of ≥2 cm renal stones Study design: This study is a
      prospective, observational, international, multicenter registry cohort study Study
      population: All patients ≥14 years with ≥2 cm renal stone who are planned for Standard-PCNL,
      Mini-PCNL or SMP are eligible for this study.
BACKGROUND AND RATIONALE Percutaneous nephrolithotomy (PCNL) is the first-choice for the
      treatment of renal stone ≥20 mm with high stone free rate (SFR). However, there are some
      sever complications such as bleeding. Severe bleeding needs arterial embolization, which
      might impair the renal function. The size of percutaneous access tract has been proven to be
      closely related to the risk of bleeding complications. Mini-PCNL was firstly introduced by
      Jackman in 1998 to treat pediatric renal stone with the aim to lower the morbidity. Mini-PCNL
      was gradually applied to adults. In recent years, urologists were still attempting to reduce
      size of the sheath and modify the sheath. They aimed to reduce the risk of bleeding. The
      first generation SMP consists of a 10-14 F access sheath with a suction-evacuation function
      and a 7-F nephroscope with enhanced irrigation was introduced by Guohua Zeng's group in 2014.
      In 2016, Guohua Zeng's group continued to introduce a modified SMP technique and system. The
      most remarkable feature of the new generation super-mini percutaneous nephrolithotomy
      (New-SMP) was metal irrigation-suction sheath which made the new system have higher
      efficiency than the old one. With the modified SMP technique and system, SMP was performed to
      treat large renal stone. (≥2cm). Moreover, SMP with an irrigation-suction sheath obviously
      improved the efficiency of removing the fragments and lower the intrapelvic pressure.

      Although miniaturized techniques decreased the bleeding-related morbidity and have a similar
      SFR, they seemed to take a longer operating time and have risk of getting infectious
      complications. However, till now, no high quality of evidence demonstrated that what size of
      tract is the best for the treatment of ≥2 cm renal stone. Perhaps the investigators should
      find out a subgroup suitable for standard-PCNL, Mini-PCNL or SMP respectively.

      STUDY OBJECTIVES The aim of this registry is to review current clinical practice on PCNL for
      stone treatment. The investigators will explore the answers to the following questions: What
      kind of PCNL urologists prefers to used? Is there a best cutoff based on the size of stones
      to divide the patients into subgroups, or a scoring system to decide which kind of PCNL is
      the best choice for individuals? Primary Objective To compare the stone free rate (SFR) (%)
      among standard-PCNL, Mini-PCNL and SMP for the treatment of ≥2 cm renal stone.

      Secondary Objectives

        1. Bleeding complication: hematocrit drop (g/L) and rate of transfusion (%).

        2. Infectious complication: rate of getting fever (≥38℃) (%) and urosepsis (%).

        3. Intraoperative indexes: operating time (mins), rate of tubeless/total tubeless (%).

        4. Postoperative indexes: hospital stay (mins), visual analogue scale (VAS) score (range
           from 0-10, the higher value represents the worse outcome) STUDY DESIGN This study is a
           prospective, observational, international, multicenter registry cohort study SELECTION
           AND ENROLLMENT OF PARTICIPANTS Clinical Recruitment All sites for this pilot study are
           recruited by IAU Members. Each participating center should obtain ethical approval, as
           needed, according to local regulations.

      Each participating centre will include all consecutive eligible patients. PCNL procedures are
      performed according local protocols and surgeons' own propensity. Data will be collected in
      the IAU online platform (http://47.74.212.47/#/login), which is developed by IAU. Each
      participating center has own account and password to login and collect data. Data analysis
      will be coordinated by IAU.

      Study Population All patients ≥14 years with ≥2 cm renal stone who are planned for
      Standard-PCNL, Mini-PCNL or SMP are eligible for this study.

      Surgical procedure The procedure of SMP, mini-PCNL and Standard-PCNL was according to
      surgeons' propensity, the related details were recorded online.
observational model: Cohort
time perspective: Prospective
measure: Stone free rate (SFR) (%)
time frame: 1-3 months after the day of DJ stent/ureteral catheter removal or the day of operation (if no DJ stent or ureteral catheter placed postoperatively).
description: Stone free rate (SFR) (%) are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the kidney which were defined as ≦ 4mm, asymptomatic, non-obstructive and non-infectious stone particles.
measure: Perioperative complications
time frame: intraoperatively or ≤ 1 month postoperatively
description: Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively, including intraoperative bleeding, postoperative pain and so on
arm group label: Standard-PCNL
description: Perform PCNL with ≥24 Fr access tract for the treatment of ≥2 renal stones
arm group label: Mini-PCNL
description: Perform PCNL with 12-20 Fr access tract for the treatment of ≥2 renal stones
arm group label: Super-mini PCNL
description: Perform SMP for the treatment of ≥2 renal stones
intervention type: Procedure
intervention name: Standard-PCNL
description: percutaneous nephrostolithotomy (PCNL) with ≥24 Fr access tract for the treatment of ≥2 cm renal stone
arm group label: Standard-PCNL
intervention type: Procedure
intervention name: Mini-PCNL
description: percutaneous nephrostolithotomy (PCNL) with 12-20 Fr access tract for the treatment of ≥2 cm renal stone
arm group label: Mini-PCNL
intervention type: Procedure
intervention name: SMP
description: percutaneous nephrostolithotomy (PCNL) with 10-14 Fr access tract for the treatment of ≥2 cm renal stone
arm group label: Super-mini PCNL
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: No
last name: Guohua Zeng, PH.D & MD
role: Principal Investigator
affiliation: The First Affiliated Hospital of Guangzhou Medical University
last name: Guohua Zeng, PH.D & MD
phone: +86 13802916676
email: gzgyzgh@vip.sina.com
last name: Chao Cai, PH.D & MD
phone: +86 13512780911
email: 673059209@qq.com
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital of Guangzhou Medical University
investigator full name: Guohua Zeng
investigator title: Vice president
mesh term: Kidney Calculi
mesh term: Nephrolithiasis
mesh term: Calculi
mesh term: Lithiasis
sharing ipd: Undecided
ipd description: It is a international multi-center prospective cohort study, the data is not available to other researchers before the agreement from all the centers