Clinical trial NCT03250559: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Kidney Disease
Keywords: Stone disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 6
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Stone free rate.
timeFrame: Day one post operative.
Secondary outcomes:
measure: The need for blood transfusion.
timeFrame: within 24 hours of the procedure.
measure: Surrounding organ injury.
timeFrame: within first 24 hours post operative.
measure: Radiation exposure.
timeFrame: within one hour during the procedure.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine-Assiut university
Study officials:
affiliation: Assiut University
name: Ahmed Elderwy, MD
role: STUDY_DIRECTOR
References:
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.