Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571617
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
F-URS and Mini PCNL for Pediatric Urolithiasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Retrograde Intrarenal Surgery Versus Mini-Percutaneous Nephrolithotomy for Treatment of Medium Size Pediatric Renal Stones 10-20millimeters A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare RIRS versus mini-perc PNL in the management of medium size pediatric renal stones 10-20 mm through a RCT
Detailed Description:
Pediatric urolithiasis has become a major health problem especially in the developing countries It is a well-known risk factor for renal impairment and end-stage kidney disease ESKD Also its associated with a bad quality of life Qol for both parents and child Children represent 2-3 of the total population of stone-formers Similar to adult urolithiasis the prevalence of pediatric stones is widely variable in different parts of the world it changes with sex race geographical and climatic factors
Renal stones in pediatric patients are usually caused by an underlying disorder such as anatomical and metabolic anomalies or recurrent urinary tract infections So children with renal stones are at higher risk for recurrence and multiple interventions on the kidney Over the last decades the management of pediatric urolithiasis had been replaced by less invasive endourological procedures and the role of open surgeries had been greatly subsided According to the last guidelines from the European Association of Urology EAU and the American urological association AUA the standard treatment of renal stones between1-2 cm is shockwave lithotripsy SWL percutaneous nephrolithotomy PNL and retrograde intrarenal surgery RIRS However the first choice between these modalities is still controversial until now
SWL is one of the most effective treatment options for pediatric stones however its long-term effect on developing kidneys is not clear yet Also its efficacy decreases significantly with increasing stone size and multiplicity The requirement for multiple sessions and the need for general anesthesia in children are other drawbacks of this procedure
PNL has significantly higher stone-free rates SFR and lower requirements for auxiliary procedures compared with SWL This trend is further promoted by the introduction of miniaturized PNL mini-perc which is postulated to be less invasive compared with standard PNL because of the miniaturized instruments However PNL may present problems in children despite modifications such as the mini-perc because of the small size and mobility of the pediatric kidney friable renal parenchyma and the small size of the collecting system
On the other hand the quality of flexible ureteroscopy and endoscopic instruments showed an outstanding development over the last years which made RIRS a feasible option for pediatric renal stones Experience suggests that flexible ureteroscopy has a lower risk of kidney damage and bleeding However the disadvantage of RIRS in children includes the need toindwell double-J stent in advance the risk of ureteral injury and the high cost of equipment purchase and maintenance which may limit the application of RIRS in children with upper urinary tract calculi
Until now there is a few number of randomized trials compared mini-perc PNL versus RIRS for pediatric renal stones SO there is no clear evidence for the superiority of one option over the other regarding stone- free rate complication rate auxiliary procedures and second sessions
Recently a new Trifecta tool which includes stone-free status in a single session without complications was set in motion to help standard reporting of the outcome of stone intervention in line with assessing its efficacy and safety
In the present study we will try to overcome the limitations of the previous studies by designing a prospective randomized controlled trial RCT To the best of our knowledge the present study is the first RCT comparing mini-perc PNL versus RIRS for the management medium -size renal stones 10-20mm in children
Renal stones in pediatric patients are usually caused by an underlying disorder such as anatomical and metabolic anomalies or recurrent urinary tract infections So children with renal stones are at higher risk for recurrence and multiple interventions on the kidney Over the last decades the management of pediatric urolithiasis had been replaced by less invasive endourological procedures and the role of open surgeries had been greatly subsided According to the last guidelines from the European Association of Urology EAU and the American urological association AUA the standard treatment of renal stones between1-2 cm is shockwave lithotripsy SWL percutaneous nephrolithotomy PNL and retrograde intrarenal surgery RIRS However the first choice between these modalities is still controversial until now
SWL is one of the most effective treatment options for pediatric stones however its long-term effect on developing kidneys is not clear yet Also its efficacy decreases significantly with increasing stone size and multiplicity The requirement for multiple sessions and the need for general anesthesia in children are other drawbacks of this procedure
PNL has significantly higher stone-free rates SFR and lower requirements for auxiliary procedures compared with SWL This trend is further promoted by the introduction of miniaturized PNL mini-perc which is postulated to be less invasive compared with standard PNL because of the miniaturized instruments However PNL may present problems in children despite modifications such as the mini-perc because of the small size and mobility of the pediatric kidney friable renal parenchyma and the small size of the collecting system
On the other hand the quality of flexible ureteroscopy and endoscopic instruments showed an outstanding development over the last years which made RIRS a feasible option for pediatric renal stones Experience suggests that flexible ureteroscopy has a lower risk of kidney damage and bleeding However the disadvantage of RIRS in children includes the need toindwell double-J stent in advance the risk of ureteral injury and the high cost of equipment purchase and maintenance which may limit the application of RIRS in children with upper urinary tract calculi
Until now there is a few number of randomized trials compared mini-perc PNL versus RIRS for pediatric renal stones SO there is no clear evidence for the superiority of one option over the other regarding stone- free rate complication rate auxiliary procedures and second sessions
Recently a new Trifecta tool which includes stone-free status in a single session without complications was set in motion to help standard reporting of the outcome of stone intervention in line with assessing its efficacy and safety
In the present study we will try to overcome the limitations of the previous studies by designing a prospective randomized controlled trial RCT To the best of our knowledge the present study is the first RCT comparing mini-perc PNL versus RIRS for the management medium -size renal stones 10-20mm in children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None