Clinical Trials Directory

Trials / Unknown

UnknownNCT03250559

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
Phase
N/A
Study type
Interventional
Enrollment
6 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
6 Months – 14 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDUREPercutaneous nephrolithotomyEndoscopic kidney stone extraction technique.

Timeline

Start date
2018-11-20
Primary completion
2022-03-01
Completion
2022-05-01
First posted
2017-08-15
Last updated
2021-07-28

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03250559. Inclusion in this directory is not an endorsement.