Ultrasonic vs. Fluoroscopic Guided PNL in Pediatric Renal Stones
Ultrasonic Versus Fluoroscopic Guided Percutaneous Nephrolithotripsy in Pediatric Renal Stones: a Prospective Randomized Study
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedStudy Start
First participant enrolled
November 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedJuly 28, 2021
July 1, 2021
3.3 years
July 23, 2017
July 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stone free rate.
Stone free rate (less than 4 mm residual is considered free).
Day one post operative.
Secondary Outcomes (3)
The need for blood transfusion.
within 24 hours of the procedure.
Surrounding organ injury.
within first 24 hours post operative.
Radiation exposure.
within one hour during the procedure.
Study Arms (2)
ultrasound guided group
ACTIVE COMPARATORThe group of renal stones that would have percutaneous nephrolithotomy under ultrasound guidance. Intervention: percutaneous nephrolithotomy.
fluoroscopy guided group
ACTIVE COMPARATORThe group of renal stones that would have percutaneous nephrolithotomy under fluoroscopy guidance. Intervention: percutaneous nephrolithotomy.
Interventions
Endoscopic kidney stone extraction technique.
Eligibility Criteria
You may qualify if:
- All kidney stones in pediatric age group and indicated for PNL.
You may not qualify if:
- Children unfit for the procedure or non indicated for it.
- Parental refusal.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of medicine-Assiut university
Asyut, Egypt
Related Publications (1)
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: 23826158BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmed Elderwy, MD
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator of urology-Assiut university
Study Record Dates
First Submitted
July 23, 2017
First Posted
August 15, 2017
Study Start
November 20, 2018
Primary Completion
March 1, 2022
Study Completion
May 1, 2022
Last Updated
July 28, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share