Clinical trial NCT06031103: Clinical Efficacy of Mini-PCNLversus RIRS for the Management of Upper Urinary Tract Calculus (1-2.5 cm)
Official title: Clinical Efficacy of Mini-Percutaneous Nephrolithotomy Versus Retrograde Intrarenal Surgery for the Management of Upper Urinary Tract Calculus (1-2.5 cm) in Children ≤10 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stone, Kidney
Keywords: Pediatric stones
retrograde intrarenal surgery
mini-per-cutaneous nephrostomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this \[ type of study:\]prospective randomized clinical trial. The main question is to compare the outcomes of mini-percutaneous nephrolithotomy (m-PCNL) and retrograde intrarenal surgery (RIRS) in treating upper urinary tract calculus in children ≤ 10 years.

Detailed description: With the increase in morbidity and incidence of pediatric kidney stone disease, childhood urolithiasis has become a significant health problem worldwide, especially in developing countries. Children with urinary calculi are at high risk for recurrent stone formation and may require multiple surgical interventions.

In recent decades, with the improvement of miniaturization of surgical equipment, the management of pediatric kidney stone disease has changed dramatically. As a result of these improvements, minimally invasive techniques, such as percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS) are alternative treatment options for children with upper urinary tract calculus.

Extracorporeal shock wave lithotripsy (ESWL) has been used for the treatment of upper urinary tract calculus \< 2 cm. but, The significantly lower stone-free rates (SFR) of SWL as compared to the PCNL and RIRS, requirement for anesthesia, the possibility of parenchymal damage to the growing kidney and the need for additional sessions are the significant limitations of SWL

Mini-percutaneous nephrolithotomy (Mini-PCNL) is an adjustment of the standard PCNL procedure after the development of small-caliber instruments that has several advantages such as a smaller skin incision, smaller tract size, and less bleeding. However, mini-PCNL may cause severe complications because of fragile parenchyma, small caliber collecting system, and mobile kidney in pediatric patients.

with the persistent advancement of endoscopic instruments and flexible ureteroscope, the examination of the upper urinary tract has become more feasible, and retrograde intrarenal surgery (RIRS) can effectively compete with PCNL. However, the outcomes of the use of flexible ureteroscope in the pediatric population such as the risk of ureteral injury, stone-free rate especially in large stones (more than 2 cm), need for the ancillary procedure, the need to indwell double-J stent in advance and high cost of instrument and maintenance remain largely unknown, resulting in controversy about the clinical safety and efficacy of PCNL and RIRS in the treatment of upper urinary tract calculus.

In the current study, the investigators aimed to compare RIRS and mini-PCNL by evaluating The operative and postoperative outcomes for children ≤10 years of age with upper urinary tract calculus (1-2.5 cm).

Eligibility criteria: Inclusion Criteria:

* This study will include all children (age \< 10 years) who undergo Mini-PCNL or RIRS with stone size (1_2.5 cm) for upper urinary tract stones

Exclusion Criteria:

* Children with urinary tract infections until treated
* Children with ureteral stricture
* Congenital urological anomalies
* Previous urological surgery

Primary outcomes:
measure: The fluoroscopy time of mini-PCNL and RIRS procedures in both groups
timeFrame: for each case in both groups the investigator assess the duration of fluoroscopy that the patient is exposed during the time of operation which range from (2-4 hours) through study completion, an average of 1.5 year"
measure: the stone free rate in both groups
timeFrame: after one month from intervention
measure: The operation time of mini-PCNL and RIRS procedures in both groups
timeFrame: for each case in both groups the investigator assess the time of operation from the induction of anesthesia till the end of operation "through study completion, an average of 1.5 year"
measure: postoperative hospital stay time of mini-PCNL and RIRS procedures in both groups
timeFrame: or each case in both groups the investigator assess the hospital time from the day of admission of patient in hospital to do intervention till patient discharge from hospital through study completion, an average of 1.5 year"
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Abdelrahman Nazmy Abbas Hatata
Study officials:
affiliation: Ain Shams University
name: mohamed sa salem, MD
role: STUDY_CHAIR
References:
citation: Lu P, Song R, Yu Y, Yang J, Qi K, Tao R, Chen K, Zhang W, Gu M. Clinical efficacy of percutaneous nephrolithotomy versus retrograde intrarenal surgery for pediatric kidney urolithiasis: A PRISMA-compliant article. Medicine (Baltimore). 2017 Oct;96(43):e8346. doi: 10.1097/MD.0000000000008346.
citation: Bastug F, Gunduz Z, Tulpar S, Poyrazoglu H, Dusunsel R. Urolithiasis in infants: evaluation of risk factors. World J Urol. 2013 Oct;31(5):1117-22. doi: 10.1007/s00345-012-0828-y. Epub 2012 Jan 19.
citation: Gao X, Fang Z, Lu C, Shen R, Dong H, Sun Y. Management of staghorn stones in special situations. Asian J Urol. 2020 Apr;7(2):130-138. doi: 10.1016/j.ajur.2019.12.014. Epub 2019 Dec 30.