Skip to content

Ultrasonic vs. Fluoroscopic Guided PNL in Pediatric Renal Stones

Ultrasonic Versus Fluoroscopic Guided Percutaneous Nephrolithotripsy in Pediatric Renal Stones: a Prospective Randomized Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03250559
Enrollment
6
Registered
2017-08-15
Start date
2018-11-20
Completion date
2022-05-31
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Kidney Disease

Keywords

Stone disease

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

Interventions

PROCEDUREPercutaneous nephrolithotomy

Endoscopic kidney stone extraction technique.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Months to 14 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Stone free rate.Day one post operative.Stone free rate (less than 4 mm residual is considered free).

Secondary

MeasureTime frameDescription
The need for blood transfusion.within 24 hours of the procedure.Amount of transfused blood (if any) in milliliters.
Surrounding organ injury.within first 24 hours post operative.Any injured surrounding organ e.g. liver, spleen or lung will be recorded with the degree of injury.
Radiation exposure.within one hour during the procedure.Amount of radiation exposure (during fluoroscopy guided PNL) in millisievert (mSv).

Countries

Egypt

Contacts

Primary ContactAyman Elqady, master
Dr.uro87@gmail.com0020882102113
Backup ContactAhmed Elderwy, MD
Ahmad.elderwy@gmail.com01063544453

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026