Clinical trial NCT05293613: Extracorporeal Shock Wave Lithotripsy for Treatment of Large Pediatric Renal Pelvic Stone Burden More Than 2 cm
Official title: Extracorporeal Shock Wave Lithotripsy for Treatment of Large Pediatric Renal Pelvic Stone Burden More Than 2 cm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age Group
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Extracorporeal shock wave lithotripsy (SWL) was first described for pediatric nephrolithiasis in 1986; SWL has been a mainstay of treatment for both renal and ureteral calculi in children . SWL is currently regarded as first-line therapy for most renal and upper ureteral calculi \<2.0 cm according to the EAU/ESPU guidelines . Meanwhile, the American Urological Association (AUA) considers SWL to be a first-line option along with URS for renal or ureteral calculi \<2.0 cm, and a first-line option along with PNL for renal calculi \>2.0 cm . The shock waves are better transmitted and spontaneous clearance of fragmented stones in pediatric kidneys is higher than adults' kidneys; thus, SWL treatment seems likely to be more successful in the pediatric population compared to the adult population .Younger age is associated with better stone clearance in children treated with SWL, and this is related mostly to increased ureteral compliance (shorter, more elastic and distensible) and shorter skin-to-stone distance .


Eligibility criteria: Inclusion Criteria:

* Age: 1 year - 5 years old. ( as children younger than 5 years old has shorter skin to stone distance \& the option of endoscopic treatment of stones has is not feasible in this age group) Stone size: more than 2 cm \& less than 3.5 cm. Stone location: renal pelvis \& other calyces.

Exclusion Criteria:

* Age: less than 1 year \& more than 5 years old. Stone size: less than 2 cm \& more than 3.5 cm. Raised serum creatinine , coagulopathy. Distal urinary tract obstruction. Pulmonary or cardiac disease Anatomical abnormalities (UPJO, horses shoe kidney, ...)

Primary outcomes:
measure: stone free rate
timeFrame: 2 months
Secondary outcomes:
measure: complications associated with pediatric SWL
timeFrame: 2 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Sultan S, Aba Umer S, Ahmed B, Naqvi SAA, Rizvi SAH. Update on Surgical Management of Pediatric Urolithiasis. Front Pediatr. 2019 Jul 3;7:252. doi: 10.3389/fped.2019.00252. eCollection 2019.
citation: Tasian GE, Copelovitch L. Evaluation and medical management of kidney stones in children. J Urol. 2014 Nov;192(5):1329-36. doi: 10.1016/j.juro.2014.04.108. Epub 2014 Jun 21.
citation: Gajengi AK, Wagaskar VG, Tanwar HV, Mhaske S, Patwardhan SK. Metabolic Evaluation in Paediatric Urolithiasis: A 4-Year Open Prospective Study. J Clin Diagn Res. 2016 Feb;10(2):PC04-6. doi: 10.7860/JCDR/2016/17265.7251. Epub 2016 Feb 1.