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Clinical Trials/NCT05293613
NCT05293613
Completed
Not Applicable

Extracorporeal Shock Wave Lithotripsy for Treatment of Large Pediatric Renal Pelvic Stone Burden More Than 2 cm

Sohag University1 site in 1 country50 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age Group
Sponsor
Sohag University
Enrollment
50
Locations
1
Primary Endpoint
stone free rate
Status
Completed
Last Updated
3 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
August 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Khalaf Elsayed

resident doctor at urolrogy department sohag university hospital

Sohag University

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, ...)

Outcomes

Primary Outcomes

stone free rate

Time Frame: 2 months

degree of stone disintegration \& expulsion form pediatric patient after going through Extracorporeal shock wave lithotripsy for treatment of large pediatric renal pelvic stone burden more than 2 cm

Secondary Outcomes

  • complications associated with pediatric SWL(2 months)

Study Sites (1)

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