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Ultrasonic vs. Fluoroscopic Guided PNL in Pediatric Renal Stones

Primary Purpose

Pediatric Kidney Disease

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Percutaneous nephrolithotomy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Kidney Disease focused on measuring Stone disease

Eligibility Criteria

6 Months - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All kidney stones in pediatric age group and indicated for PNL.

Exclusion Criteria:

  • Children unfit for the procedure or non indicated for it.
  • Parental refusal.

Sites / Locations

  • Faculty of medicine-Assiut universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ultrasound guided group

fluoroscopy guided group

Arm Description

The group of renal stones that would have percutaneous nephrolithotomy under ultrasound guidance. Intervention: percutaneous nephrolithotomy.

The group of renal stones that would have percutaneous nephrolithotomy under fluoroscopy guidance. Intervention: percutaneous nephrolithotomy.

Outcomes

Primary Outcome Measures

Stone free rate.
Stone free rate (less than 4 mm residual is considered free).

Secondary Outcome Measures

The need for blood transfusion.
Amount of transfused blood (if any) in milliliters.
Surrounding organ injury.
Any injured surrounding organ e.g. liver, spleen or lung will be recorded with the degree of injury.
Radiation exposure.
Amount of radiation exposure (during fluoroscopy guided PNL) in millisievert (mSv).

Full Information

First Posted
July 23, 2017
Last Updated
July 26, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03250559
Brief Title
Ultrasonic vs. Fluoroscopic Guided PNL in Pediatric Renal Stones
Official Title
Ultrasonic Versus Fluoroscopic Guided Percutaneous Nephrolithotripsy in Pediatric Renal Stones: a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Kidney Disease
Keywords
Stone disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ultrasound guided group
Arm Type
Active Comparator
Arm Description
The group of renal stones that would have percutaneous nephrolithotomy under ultrasound guidance. Intervention: percutaneous nephrolithotomy.
Arm Title
fluoroscopy guided group
Arm Type
Active Comparator
Arm Description
The group of renal stones that would have percutaneous nephrolithotomy under fluoroscopy guidance. Intervention: percutaneous nephrolithotomy.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous nephrolithotomy
Other Intervention Name(s)
percutaneous nephrolithotripsy (PNL)
Intervention Description
Endoscopic kidney stone extraction technique.
Primary Outcome Measure Information:
Title
Stone free rate.
Description
Stone free rate (less than 4 mm residual is considered free).
Time Frame
Day one post operative.
Secondary Outcome Measure Information:
Title
The need for blood transfusion.
Description
Amount of transfused blood (if any) in milliliters.
Time Frame
within 24 hours of the procedure.
Title
Surrounding organ injury.
Description
Any injured surrounding organ e.g. liver, spleen or lung will be recorded with the degree of injury.
Time Frame
within first 24 hours post operative.
Title
Radiation exposure.
Description
Amount of radiation exposure (during fluoroscopy guided PNL) in millisievert (mSv).
Time Frame
within one hour during the procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All kidney stones in pediatric age group and indicated for PNL. Exclusion Criteria: Children unfit for the procedure or non indicated for it. Parental refusal.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayman Elqady, master
Phone
0020882102113
Email
Dr.uro87@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Elderwy, MD
Phone
01063544453
Email
Ahmad.elderwy@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Elderwy, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of medicine-Assiut university
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad El-Sharkawi, MD
Phone
0020882412245
Email
mohamed.elsharkawy@med.au.edu.eg
First Name & Middle Initial & Last Name & Degree
Maha Omar, MD
Phone
0020882413660
Email
mahaghanem@aun.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23826158
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.
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Ultrasonic vs. Fluoroscopic Guided PNL in Pediatric Renal Stones

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