xml: <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/NCT06031103</url>
    </required_header>
    <id_info>
      <org_study_id>Pediatric renal stones</org_study_id>
      <nct_id>NCT06031103</nct_id>
    </id_info>
    <brief_title>Clinical Efficacy of Mini-PCNLversus RIRS for the Management of Upper Urinary Tract Calculus (1-2.5 cm)</brief_title>
    <official_title>Clinical Efficacy of Mini-Percutaneous Nephrolithotomy Versus Retrograde Intrarenal Surgery for the Management of Upper Urinary Tract Calculus (1-2.5 cm) in Children ≤10 Years of Age</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this [ type of study:]prospective randomized clinical trial. The main question is&#xD;
        to compare the outcomes of mini-percutaneous nephrolithotomy (m-PCNL) and retrograde&#xD;
        intrarenal surgery (RIRS) in treating upper urinary tract calculus in children ≤ 10 years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        With the increase in morbidity and incidence of pediatric kidney stone disease, childhood&#xD;
        urolithiasis has become a significant health problem worldwide, especially in developing&#xD;
        countries. Children with urinary calculi are at high risk for recurrent stone formation and&#xD;
        may require multiple surgical interventions.&#xD;
  &#xD;
        In recent decades, with the improvement of miniaturization of surgical equipment, the&#xD;
        management of pediatric kidney stone disease has changed dramatically. As a result of these&#xD;
        improvements, minimally invasive techniques, such as percutaneous nephrolithotomy (PCNL) and&#xD;
        retrograde intrarenal surgery (RIRS) are alternative treatment options for children with&#xD;
        upper urinary tract calculus.&#xD;
  &#xD;
        Extracorporeal shock wave lithotripsy (ESWL) has been used for the treatment of upper urinary&#xD;
        tract calculus &lt; 2 cm. but, The significantly lower stone-free rates (SFR) of SWL as compared&#xD;
        to the PCNL and RIRS, requirement for anesthesia, the possibility of parenchymal damage to&#xD;
        the growing kidney and the need for additional sessions are the significant limitations of&#xD;
        SWL&#xD;
  &#xD;
        Mini-percutaneous nephrolithotomy (Mini-PCNL) is an adjustment of the standard PCNL procedure&#xD;
        after the development of small-caliber instruments that has several advantages such as a&#xD;
        smaller skin incision, smaller tract size, and less bleeding. However, mini-PCNL may cause&#xD;
        severe complications because of fragile parenchyma, small caliber collecting system, and&#xD;
        mobile kidney in pediatric patients.&#xD;
  &#xD;
        with the persistent advancement of endoscopic instruments and flexible ureteroscope, the&#xD;
        examination of the upper urinary tract has become more feasible, and retrograde intrarenal&#xD;
        surgery (RIRS) can effectively compete with PCNL. However, the outcomes of the use of&#xD;
        flexible ureteroscope in the pediatric population such as the risk of ureteral injury,&#xD;
        stone-free rate especially in large stones (more than 2 cm), need for the ancillary&#xD;
        procedure, the need to indwell double-J stent in advance and high cost of instrument and&#xD;
        maintenance remain largely unknown, resulting in controversy about the clinical safety and&#xD;
        efficacy of PCNL and RIRS in the treatment of upper urinary tract calculus.&#xD;
  &#xD;
        In the current study, the investigators aimed to compare RIRS and mini-PCNL by evaluating The&#xD;
        operative and postoperative outcomes for children ≤10 years of age with upper urinary tract&#xD;
        calculus (1-2.5 cm).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Actual">August 1, 2023</completion_date>
    <primary_completion_date type="Actual">July 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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The fluoroscopy time of mini-PCNL and RIRS procedures in both groups</measure>
      <time_frame>for each case in both groups the investigator assess the duration of fluoroscopy that the patient is exposed during the time of operation which range from (2-4 hours) through study completion, an average of 1.5 year&quot;</time_frame>
      <description>the duration of fluoroscopy time measured by seconds that the patient is exposed to during the procedure in both groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>the stone free rate in both groups</measure>
      <time_frame>after one month from intervention</time_frame>
      <description>Procedures will be accepted as stone free when there are no residual fragments or stone fragments &lt;3 mm at follow-up CTUT</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The operation time of mini-PCNL and RIRS procedures in both groups</measure>
      <time_frame>for each case in both groups the investigator assess the time of operation from the induction of anesthesia till the end of operation &quot;through study completion, an average of 1.5 year&quot;</time_frame>
      <description>the time of procedure measured by minutes in both groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>postoperative hospital stay time of mini-PCNL and RIRS procedures in both groups</measure>
      <time_frame>or each case in both groups the investigator assess the hospital time from the day of admission of patient in hospital to do intervention till patient discharge from hospital through study completion, an average of 1.5 year&quot;</time_frame>
      <description>the post operative hospital stay measured by hours</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Stone, Kidney</condition>
    <arm_group>
      <arm_group_label>childhood urolithiasis treated with mini PCNL Procedure</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>pediatric patients with upper urinary tract calculus treated with mini-PCNL procedure</description>
    </arm_group>
    <arm_group>
      <arm_group_label>childhood urolithiasis treated with RIRS Procedure</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>pediatric patients with upper urinary tract calculus treated with mini-PCNL procedure</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>mini-PCNL procedure</intervention_name>
      <description>Mini-PCNL&#xD;
  . A 12 Fr rigid nephroscope and a Holmium:YAG laser as energy source was used for surgery Percutaneous renal puncture was achieved with an 18 Ga needle after displaying renal collecting system with contrast material. and tract dilatation was achieved using Amplatz dilators up to 16-18 Fr according to patient age</description>
      <arm_group_label>childhood urolithiasis treated with mini PCNL Procedure</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>RIRS procedure</intervention_name>
      <description>RIRS Technique the 9.5 Fr ureteral access sheath (UAS). UAS was inserted over the guide wire under fluoroscopy control. A flexible ureteroscope was passed through the UAS. If the UAS did not pass over the guide wire, the investigator moved the flexible ureteroscopy over the guide wire without access sheat</description>
      <arm_group_label>childhood urolithiasis treated with RIRS Procedure</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  This study will include all children (age &lt; 10 years) who undergo Mini-PCNL or RIRS&#xD;
               with stone size (1_2.5 cm) for upper urinary tract stones&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with urinary tract infections until treated&#xD;
  &#xD;
            -  Children with ureteral stricture&#xD;
  &#xD;
            -  Congenital urological anomalies&#xD;
  &#xD;
            -  Previous urological surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Month</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>mohamed sa salem, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Abdelrahman Nazmy Abbas Hatata</name>
        <address>
          <city>Cairo</city>
          <zip>11511</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Lu P, Song R, Yu Y, Yang J, Qi K, Tao R, Chen K, Zhang W, Gu M. Clinical efficacy of percutaneous nephrolithotomy versus retrograde intrarenal surgery for pediatric kidney urolithiasis: A PRISMA-compliant article. Medicine (Baltimore). 2017 Oct;96(43):e8346. doi: 10.1097/MD.0000000000008346.</citation>
      <PMID>29069011</PMID>
    </reference>
    <reference>
      <citation>Bastug F, Gunduz Z, Tulpar S, Poyrazoglu H, Dusunsel R. Urolithiasis in infants: evaluation of risk factors. World J Urol. 2013 Oct;31(5):1117-22. doi: 10.1007/s00345-012-0828-y. Epub 2012 Jan 19.</citation>
      <PMID>22258667</PMID>
    </reference>
    <reference>
      <citation>Gao X, Fang Z, Lu C, Shen R, Dong H, Sun Y. Management of staghorn stones in special situations. Asian J Urol. 2020 Apr;7(2):130-138. doi: 10.1016/j.ajur.2019.12.014. Epub 2019 Dec 30.</citation>
      <PMID>32257806</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pediatric stones</keyword>
    <keyword>retrograde intrarenal surgery</keyword>
    <keyword>mini-per-cutaneous nephrostomy</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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031103
  org study id: Pediatric renal stones
  nct id: NCT06031103
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this [ type of study:]prospective randomized clinical trial. The main question is
        to compare the outcomes of mini-percutaneous nephrolithotomy (m-PCNL) and retrograde
        intrarenal surgery (RIRS) in treating upper urinary tract calculus in children ≤ 10 years.
  With the increase in morbidity and incidence of pediatric kidney stone disease, childhood
        urolithiasis has become a significant health problem worldwide, especially in developing
        countries. Children with urinary calculi are at high risk for recurrent stone formation and
        may require multiple surgical interventions.
  
        In recent decades, with the improvement of miniaturization of surgical equipment, the
        management of pediatric kidney stone disease has changed dramatically. As a result of these
        improvements, minimally invasive techniques, such as percutaneous nephrolithotomy (PCNL) and
        retrograde intrarenal surgery (RIRS) are alternative treatment options for children with
        upper urinary tract calculus.
  
        Extracorporeal shock wave lithotripsy (ESWL) has been used for the treatment of upper urinary
        tract calculus < 2 cm. but, The significantly lower stone-free rates (SFR) of SWL as compared
        to the PCNL and RIRS, requirement for anesthesia, the possibility of parenchymal damage to
        the growing kidney and the need for additional sessions are the significant limitations of
        SWL
  
        Mini-percutaneous nephrolithotomy (Mini-PCNL) is an adjustment of the standard PCNL procedure
        after the development of small-caliber instruments that has several advantages such as a
        smaller skin incision, smaller tract size, and less bleeding. However, mini-PCNL may cause
        severe complications because of fragile parenchyma, small caliber collecting system, and
        mobile kidney in pediatric patients.
  
        with the persistent advancement of endoscopic instruments and flexible ureteroscope, the
        examination of the upper urinary tract has become more feasible, and retrograde intrarenal
        surgery (RIRS) can effectively compete with PCNL. However, the outcomes of the use of
        flexible ureteroscope in the pediatric population such as the risk of ureteral injury,
        stone-free rate especially in large stones (more than 2 cm), need for the ancillary
        procedure, the need to indwell double-J stent in advance and high cost of instrument and
        maintenance remain largely unknown, resulting in controversy about the clinical safety and
        efficacy of PCNL and RIRS in the treatment of upper urinary tract calculus.
  
        In the current study, the investigators aimed to compare RIRS and mini-PCNL by evaluating The
        operative and postoperative outcomes for children ≤10 years of age with upper urinary tract
        calculus (1-2.5 cm).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The fluoroscopy time of mini-PCNL and RIRS procedures in both groups
  time frame: for each case in both groups the investigator assess the duration of fluoroscopy that the patient is exposed during the time of operation which range from (2-4 hours) through study completion, an average of 1.5 year"
  description: the duration of fluoroscopy time measured by seconds that the patient is exposed to during the procedure in both groups
  measure: the stone free rate in both groups
  time frame: after one month from intervention
  description: Procedures will be accepted as stone free when there are no residual fragments or stone fragments <3 mm at follow-up CTUT
  measure: The operation time of mini-PCNL and RIRS procedures in both groups
  time frame: for each case in both groups the investigator assess the time of operation from the induction of anesthesia till the end of operation "through study completion, an average of 1.5 year"
  description: the time of procedure measured by minutes in both groups
  measure: postoperative hospital stay time of mini-PCNL and RIRS procedures in both groups
  time frame: or each case in both groups the investigator assess the hospital time from the day of admission of patient in hospital to do intervention till patient discharge from hospital through study completion, an average of 1.5 year"
  description: the post operative hospital stay measured by hours
  arm group label: childhood urolithiasis treated with mini PCNL Procedure
  arm group type: Active Comparator
  description: pediatric patients with upper urinary tract calculus treated with mini-PCNL procedure
  arm group label: childhood urolithiasis treated with RIRS Procedure
  arm group type: Active Comparator
  description: pediatric patients with upper urinary tract calculus treated with mini-PCNL procedure
  intervention type: Procedure
  intervention name: mini-PCNL procedure
  description: Mini-PCNL
  . A 12 Fr rigid nephroscope and a Holmium:YAG laser as energy source was used for surgery Percutaneous renal puncture was achieved with an 18 Ga needle after displaying renal collecting system with contrast material. and tract dilatation was achieved using Amplatz dilators up to 16-18 Fr according to patient age
  arm group label: childhood urolithiasis treated with mini PCNL Procedure
  intervention type: Procedure
  intervention name: RIRS procedure
  description: RIRS Technique the 9.5 Fr ureteral access sheath (UAS). UAS was inserted over the guide wire under fluoroscopy control. A flexible ureteroscope was passed through the UAS. If the UAS did not pass over the guide wire, the investigator moved the flexible ureteroscopy over the guide wire without access sheat
  arm group label: childhood urolithiasis treated with RIRS Procedure
  criteria: 
  gender: All
  minimum age: 1 Month
  maximum age: 10 Years
  healthy volunteers: No
  last name: mohamed sa salem, MD
  role: Study Chair
  affiliation: Ain Shams University
  facility: 
  country: Egypt
  citation: Lu P, Song R, Yu Y, Yang J, Qi K, Tao R, Chen K, Zhang W, Gu M. Clinical efficacy of percutaneous nephrolithotomy versus retrograde intrarenal surgery for pediatric kidney urolithiasis: A PRISMA-compliant article. Medicine (Baltimore). 2017 Oct;96(43):e8346. doi: 10.1097/MD.0000000000008346.
  PMID: 29069011
  citation: Bastug F, Gunduz Z, Tulpar S, Poyrazoglu H, Dusunsel R. Urolithiasis in infants: evaluation of risk factors. World J Urol. 2013 Oct;31(5):1117-22. doi: 10.1007/s00345-012-0828-y. Epub 2012 Jan 19.
  PMID: 22258667
  citation: Gao X, Fang Z, Lu C, Shen R, Dong H, Sun Y. Management of staghorn stones in special situations. Asian J Urol. 2020 Apr;7(2):130-138. doi: 10.1016/j.ajur.2019.12.014. Epub 2019 Dec 30.
  PMID: 32257806
  responsible party type: Sponsor
  mesh term: Kidney Calculi
  mesh term: Nephrolithiasis
  mesh term: Calculi
  sharing ipd: No