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临床试验/NCT07700251
NCT07700251招募中不适用

Retrograde Intrarenal Surgery Versus Mini Percutaneous Nephrolithotomy In Management Of Pediatric Renal Stone Less Than 2 Cm: A Prospective Randomized Study

South Valley University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Measure Stone-Free Rate:

研究概览

简要总结

Pediatric nephrolithiasis accounts for approximately 2-3% of all stone disease cases, with recent reports indicating a rising prevalence of up to 10.6%. This increasing incidence poses a growing public health concern. The primary objective in managing pediatric renal stones is complete stone clearance while minimizing complications and improving the patient's quality of life.

详细描述

Pediatric nephrolithiasis accounts for approximately 2-3% of all stone disease cases, with recent reports indicating a rising prevalence of up to 10.6%.Multiple treatment modalities are currently available, ranging from non-invasive pharmacologic options to minimally invasive techniques such as extracorporeal shockwave lithotripsy (ESWL), retrograde intrarenal surgery (RIRS), and percutaneous nephrolithotomy (PCNL).

Treatment selection is primarily guided by stone size, location, and complexity. Importantly, the chosen intervention should aim to achieve a high stone-free rate (SFR) with the lowest possible complication rate.

Minimally invasive technique is considered the first-line of treatment for renal stones in children due to its favorable safety profile and minimally invasive nature. In such cases, endourological options like RIRS and mini-PCNL serve as favourable line of treatments.

RIRS is a minimally invasive procedure that offers advantages such as reduced perioperative morbidity, lower bleeding risk, and quicker recovery compared to mini PCNL. Nonetheless, its stone clearance rate may be inferior to mini PCNL, particularly for larger stones. RIRS often requires DJ stenting and may lead to repeated interventions, which can result in lower urinary tract symptoms (LUTS) and negative impact on quality of life.

Mini-PCNL, although highly effective, carries a higher risk of complications, including bleeding and adjucnt oragan injury particularly due to tract dilation.To reduce these risks, modified PCNL techniques have been introduced, such as ultramini-PCNL, and micro-PCNL. These smaller-caliber systems have demonstrated greater safety profiles in children and higher efficacy than ESWL, making them promising in pediatric stone management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children aged 1 to 18 years .
  • Presence of a renal stone ≤2 cm in maximum diameter (single or multiple).
  • Stone located in the renal pelvis and/or calyces.
  • Normal renal function (based on age-adjusted serum creatinine and/or eGFR).
  • No prior surgical intervention for the current stone episode.

排除标准

  • Anatomical abnormalities of the urinary tract (e.g., ureteropelvic junction obstruction, horseshoe kidney).
  • Bleeding disorders or uncorrected coagulopathy.
  • Active urinary tract infection at the time of surgery.
  • Patients with contraindications to general anesthesia.

研究组 & 干预措施

Percutaneous Nephrolithotomy Group

Active Comparator

About 30 child suffering from renal stone will undergo mini percutaneous nephrolithotomy

干预措施: Retrograde Intrarenal Surgery (Procedure)

Retrograde Intrarenal Surgery Group

Active Comparator

About 30 child suffering from renal stone will undergo retrograde intrarenal surgery

干预措施: Retrograde Intrarenal Surgery (Procedure)

结局指标

主要结局

Measure Stone-Free Rate:

时间窗: 6 months

Defined as the absence of residual stones or the presence of clinically insignificant residual fragments (CIRF) \<4 mm or absent and this will be better results, but if Clinical significant residual fragments \> or Equal 4 mm may need Auxillary procedure Evaluation the patients after the operation by Stone-Free Rate as an indicator of surgical success.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Mahmoud Rashed Aly

Lecturer at Urology Department, Faculty of Medicine

South Valley University

研究点 (1)

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