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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-08-01

Brief Summary

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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 .

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Detailed Description

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Conditions

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Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age Group

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cases

Group Type EXPERIMENTAL

extracorporeal shock wave lithotripsy

Intervention Type DEVICE

shock wave transmited from the device through patient body towards the stone to disintegrate it

Interventions

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extracorporeal shock wave lithotripsy

shock wave transmited from the device through patient body towards the stone to disintegrate it

Intervention Type DEVICE

Eligibility Criteria

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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, ...)

Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes