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Completed

NCT Number: NCT05293613

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

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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Key information

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University Hospital

Sohag, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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, ...)

Treatment and study plan

extracorporeal shock wave lithotripsy

Device

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

Primary outcomes

  1. 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

  1. complications associated with pediatric SWL

    Time frame: 2 months

    Study complications associated with pediatric SWL with large stone burden > 2cm

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2022
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.