<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/NCT03250559</url>
  </required_header>
  <id_info>
    <org_study_id>IRB000087618</org_study_id>
    <nct_id>NCT03250559</nct_id>
  </id_info>
  <brief_title>Ultrasonic vs. Fluoroscopic Guided PNL in Pediatric Renal Stones</brief_title>
  <official_title>Ultrasonic Versus Fluoroscopic Guided Percutaneous Nephrolithotripsy in Pediatric Renal Stones: a Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Percutaneous Nephrolithotomy (PNL) was accepted as a treatment modality for large renal&#xD;
      stones since 1980. Although radiation exposure during PNL is within the safe limits for&#xD;
      expert endourologist, the mutagenic hazard is still present especially in pediatric&#xD;
      population. Therefore, employing an alternative imaging technique during PNL would be of&#xD;
      added advantage. So, the investigators want to compare the efficacy of ultrasound guided PNL&#xD;
      with the conventional (fluoroscopy guided) PNL in pediatric population. If ultrasound guided&#xD;
      PNL was as effective as conventional one, this means that many children could be protected&#xD;
      from the variable hazards of radiation exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The incidence of pediatric urolithiasis varies by geographic area. Most cases of pediatric&#xD;
      urolithiasis are associated with anatomic or metabolic abnormalities or urinary tract&#xD;
      infection . PNL can be performed safely and effectively in children by experienced surgeons,&#xD;
      resulting in a high stone-free rate and lower requirement for ancillary treatment. In adults,&#xD;
      PNL is performed under fluoroscopic or ultrasound guidance. In pediatric age group,&#xD;
      fluoroscopic guidance was preferred in most of the reported studies. However, fluoroscopy&#xD;
      exposes the patient to radiation. The International Commission on Radiological Protection&#xD;
      recommends that whole body exposure in adults should be limited to an effective dose of 20&#xD;
      mSv per year over 5 years. In young children, it is particularly important to protect the&#xD;
      developing gonads and thyroid gland, as the long-term effects of exposing these organs to&#xD;
      radiation are still unclear. In contrast to fluoroscopic guidance, ultrasound guidance does&#xD;
      not expose the patient to radiation, it also can provide real-time monitoring during the&#xD;
      puncturing procedure. The path and depth of the needle, and the anatomy in and around the&#xD;
      kidney, are clearly visible on ultrasound examination&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Anticipated">March 2022</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stone free rate.</measure>
    <time_frame>Day one post operative.</time_frame>
    <description>Stone free rate (less than 4 mm residual is considered free).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The need for blood transfusion.</measure>
    <time_frame>within 24 hours of the procedure.</time_frame>
    <description>Amount of transfused blood (if any) in milliliters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surrounding organ injury.</measure>
    <time_frame>within first 24 hours post operative.</time_frame>
    <description>Any injured surrounding organ e.g. liver, spleen or lung will be recorded with the degree of injury.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation exposure.</measure>
    <time_frame>within one hour during the procedure.</time_frame>
    <description>Amount of radiation exposure (during fluoroscopy guided PNL) in millisievert (mSv).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">6</enrollment>
  <condition>Pediatric Kidney Disease</condition>
  <arm_group>
    <arm_group_label>ultrasound guided group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The group of renal stones that would have percutaneous nephrolithotomy under ultrasound guidance.&#xD;
Intervention: percutaneous nephrolithotomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fluoroscopy guided group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The group of renal stones that would have percutaneous nephrolithotomy under fluoroscopy guidance.&#xD;
Intervention: percutaneous nephrolithotomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous nephrolithotomy</intervention_name>
    <description>Endoscopic kidney stone extraction technique.</description>
    <arm_group_label>fluoroscopy guided group</arm_group_label>
    <arm_group_label>ultrasound guided group</arm_group_label>
    <other_name>percutaneous nephrolithotripsy (PNL)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All kidney stones in pediatric age group and indicated for PNL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children unfit for the procedure or non indicated for it.&#xD;
&#xD;
          -  Parental refusal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Elderwy, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ayman Elqady, master</last_name>
    <phone>0020882102113</phone>
    <email>Dr.uro87@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed Elderwy, MD</last_name>
    <phone>01063544453</phone>
    <email>Ahmad.elderwy@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of medicine-Assiut university</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammad El-Sharkawi, MD</last_name>
      <phone>0020882412245</phone>
      <email>mohamed.elsharkawy@med.au.edu.eg</email>
    </contact>
    <contact_backup>
      <last_name>Maha Omar, MD</last_name>
      <phone>0020882413660</phone>
      <email>mahaghanem@aun.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Zeng G, Zhao Z, Wan S, Zhong W, Wu W. Comparison of children versus adults undergoing mini-percutaneous nephrolithotomy: large-scale analysis of a single institution. PLoS One. 2013 Jun 24;8(6):e66850. doi: 10.1371/journal.pone.0066850. Print 2013.</citation>
    <PMID>23826158</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ayman Asem Elqady</investigator_full_name>
    <investigator_title>Principal investigator of urology-Assiut university</investigator_title>
  </responsible_party>
  <keyword>Stone disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</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/NCT03250559
org study id: IRB000087618
nct id: NCT03250559
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Percutaneous Nephrolithotomy (PNL) was accepted as a treatment modality for large renal
      stones since 1980. Although radiation exposure during PNL is within the safe limits for
      expert endourologist, the mutagenic hazard is still present especially in pediatric
      population. Therefore, employing an alternative imaging technique during PNL would be of
      added advantage. So, the investigators want to compare the efficacy of ultrasound guided PNL
      with the conventional (fluoroscopy guided) PNL in pediatric population. If ultrasound guided
      PNL was as effective as conventional one, this means that many children could be protected
      from the variable hazards of radiation exposure.
The incidence of pediatric urolithiasis varies by geographic area. Most cases of pediatric
      urolithiasis are associated with anatomic or metabolic abnormalities or urinary tract
      infection . PNL can be performed safely and effectively in children by experienced surgeons,
      resulting in a high stone-free rate and lower requirement for ancillary treatment. In adults,
      PNL is performed under fluoroscopic or ultrasound guidance. In pediatric age group,
      fluoroscopic guidance was preferred in most of the reported studies. However, fluoroscopy
      exposes the patient to radiation. The International Commission on Radiological Protection
      recommends that whole body exposure in adults should be limited to an effective dose of 20
      mSv per year over 5 years. In young children, it is particularly important to protect the
      developing gonads and thyroid gland, as the long-term effects of exposing these organs to
      radiation are still unclear. In contrast to fluoroscopic guidance, ultrasound guidance does
      not expose the patient to radiation, it also can provide real-time monitoring during the
      puncturing procedure. The path and depth of the needle, and the anatomy in and around the
      kidney, are clearly visible on ultrasound examination
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Stone free rate.
time frame: Day one post operative.
description: Stone free rate (less than 4 mm residual is considered free).
measure: The need for blood transfusion.
time frame: within 24 hours of the procedure.
description: Amount of transfused blood (if any) in milliliters.
measure: Surrounding organ injury.
time frame: within first 24 hours post operative.
description: Any injured surrounding organ e.g. liver, spleen or lung will be recorded with the degree of injury.
measure: Radiation exposure.
time frame: within one hour during the procedure.
description: Amount of radiation exposure (during fluoroscopy guided PNL) in millisievert (mSv).
arm group label: ultrasound guided group
arm group type: Active Comparator
description: The group of renal stones that would have percutaneous nephrolithotomy under ultrasound guidance.
Intervention: percutaneous nephrolithotomy.
arm group label: fluoroscopy guided group
arm group type: Active Comparator
description: The group of renal stones that would have percutaneous nephrolithotomy under fluoroscopy guidance.
Intervention: percutaneous nephrolithotomy.
intervention type: Procedure
intervention name: Percutaneous nephrolithotomy
description: Endoscopic kidney stone extraction technique.
arm group label: fluoroscopy guided group
arm group label: ultrasound guided group
other name: percutaneous nephrolithotripsy (PNL)
criteria: 
gender: All
minimum age: 6 Months
maximum age: 14 Years
healthy volunteers: No
last name: Ahmed Elderwy, MD
role: Study Director
affiliation: Assiut University
last name: Ayman Elqady, master
phone: 0020882102113
email: Dr.uro87@gmail.com
last name: Ahmed Elderwy, MD
phone: 01063544453
email: Ahmad.elderwy@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
citation: Zeng G, Zhao Z, Wan S, Zhong W, Wu W. Comparison of children versus adults undergoing mini-percutaneous nephrolithotomy: large-scale analysis of a single institution. PLoS One. 2013 Jun 24;8(6):e66850. doi: 10.1371/journal.pone.0066850. Print 2013.
PMID: 23826158
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ayman Asem Elqady
investigator title: Principal investigator of urology-Assiut university
mesh term: Kidney Diseases
sharing ipd: No