Clinical Efficacy of Mini-PCNLversus RIRS for the Management of Upper Urinary Tract Calculus (1-2.5 cm)
Condition: Stone, Kidney
MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi
Study type: Interventional

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).
    

Intervention name(s): mini-PCNL procedure; RIRS procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): Mini-PCNL
. A 12 Fr rigid nephroscope and a Holmium:YAG laser as energy source was used for surgery Percutaneous renal puncture was achieved with an 18 Ga needle after displaying renal collecting system with contrast material. and tract dilatation was achieved using Amplatz dilators up to 16-18 Fr according to patient age; RIRS Technique the 9.5 Fr ureteral access sheath (UAS). UAS was inserted over the guide wire under fluoroscopy control. A flexible ureteroscope was passed through the UAS. If the UAS did not pass over the guide wire, the investigator moved the flexible ureteroscopy over the guide wire without access sheat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric stones; retrograde intrarenal surgery; mini-per-cutaneous nephrostomy