- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05293613
Extracorporeal Shock Wave Lithotripsy for Treatment of Large Pediatric Renal Pelvic Stone Burden More Than 2 cm
August 31, 2022 updated by: Ahmed Khalaf Elsayed, Sohag University
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 .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sohag, Egypt
- Sohag University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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, ...)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cases
|
shock wave transmited from the device through patient body towards the stone to disintegrate it
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complications associated with pediatric SWL
Time Frame: 2 months
|
Study complications associated with pediatric SWL with large stone burden > 2cm
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
August 1, 2022
Study Completion (Actual)
August 1, 2022
Study Registration Dates
First Submitted
March 15, 2022
First Submitted That Met QC Criteria
March 15, 2022
First Posted (Actual)
March 24, 2022
Study Record Updates
Last Update Posted (Actual)
September 1, 2022
Last Update Submitted That Met QC Criteria
August 31, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh_Med_22_03_04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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