Back to resultsExtracorporeal Shock Wave Lithotripsy for Treatment of Large Pediatric Renal Pelvic Stone Burden More Than 2 cm
Primary Purpose
Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age Group
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
extracorporeal shock wave lithotripsy
Sponsored by
About this trial
This is an interventional treatment trial for Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age Group
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, ...)
Sites / Locations
- Sohag University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cases
Arm Description
Outcomes
Primary Outcome Measures
stone free rate
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 Outcome Measures
complications associated with pediatric SWL
Study complications associated with pediatric SWL with large stone burden > 2cm
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05293613
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age Group
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cases
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
extracorporeal shock wave lithotripsy
Intervention Description
shock wave transmited from the device through patient body towards the stone to disintegrate it
Primary Outcome Measure Information:
Title
stone free rate
Description
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
Time Frame
2 months
Secondary Outcome Measure Information:
Title
complications associated with pediatric SWL
Description
Study complications associated with pediatric SWL with large stone burden > 2cm
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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, ...)
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
31334207
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.
Results Reference
background
PubMed Identifier
24960469
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.
Results Reference
background
PubMed Identifier
27042515
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.
Results Reference
background
Learn more about this trial
Extracorporeal Shock Wave Lithotripsy for Treatment of Large Pediatric Renal Pelvic Stone Burden More Than 2 cm
We'll reach out to this number within 24 hrs