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Efficacy and Safety of Flexible Ureteroscopy With Flexible Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheath

2026年8月10日 更新者:Mohamed Ramadan、Ain Shams University

A Comparative Study on the Efficacy and Safety of Flexible Ureteroscopy With Flexible Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheath for the Management of Renal Stones 1- 2.5 cm in Pediatric Age Group

Mini-percutaneous nephrolithotomy (mini-PCNL) and retrograde intrarenal surgery (RIRS) are both effective treatment modalities for renal calculi measuring up to 2.5 cm in pediatric patients, demonstrating similar efficacy and complication profiles.

Suction has emerged as a potentially transformative adjunct in both percutaneous nephrolithotomy (PCNL) and RIRS. Recent studies evaluating various suction mechanisms during RIRS and mini-PCNL have demonstrated multiple benefits, including reduced operative time, higher stone-free rates (SFR), decreased intrarenal pressure (IRP) and temperature, as well as enhanced intraoperative visualization.

Both FANS-UAS in RIRS and VAAS in Mini-PCNL have shown promising outcomes in the pediatric population. Taken together, these findings suggest that suction-assisted technologies whether in RIRS or Mini-PCNL enhance both efficacy and safety in pediatric stone management.

研究概览

地位

招聘中

详细说明

In children, renal stones commonly result from congenital anatomical defects, metabolic abnormalities, or recurrent urinary tract infections. Consequently, urolithiasis is more frequent in this age group and often requires more than one surgical intervention for complete management.

Mini-percutaneous nephrolithotomy (mini-PCNL) and retrograde intrarenal surgery (RIRS) are both effective treatment modalities for renal calculi measuring up to 2.5 cm in pediatric patients, demonstrating similar efficacy and complication profiles .

Currently, the majority of pediatric renal stones can be managed effectively using shock wave lithotripsy (SWL), retrograde intrarenal surgery (RIRS), or percutaneous nephrolithotomy (PCNL). Surgical interventions such as open, laparoscopic, or robotic surgery are reserved for a minority of cases involving anatomical abnormalities. As spontaneous passage of residual fragments occurs in only 20-25% of cases, achieving complete stone clearance is essential to minimize the risk of recurrence and additional interventions.

Technological advancements in endourological instrumentation have primarily aimed at minimizing procedure-related morbidity, including blood loss, postoperative pain, and renal injury. Consequently, miniaturized endoscopes and reduced-caliber access tracts (11-20 Fr) were developed, leading to the emergence of Mini-PCNL techniques specifically adapted for the management of large renal stones in pediatric patients.

The use of retrograde surgical approaches has expanded the capability to treat larger renal stones, despite often resulting in extended operative times. Due to its favorable safety profile and reduced complication rates, RIRS has gained acceptance as a preferred option for managing larger stones in pediatric patients.

For stones larger than 20 mm, RIRS monotherapy is associated with lower stone-free rate (SFR) compared to Mini-PCNL. However, RIRS offers advantages including reduced radiation exposure, fewer complications, and shorter hospital stay.

The Mini-PCNL and RIRS provide comparable efficacy and complication rates in the treatment of pediatric renal stones up to 2.5 cm. Furthermore, the study found that RIRS was associated with significantly shorter hospital stays, reduced radiation exposure, and decreased fluoroscopy time compared to Mini-PCNL.

Suction has been utilized in endourology for over 25 years, primarily in conjunction with ultrasound and ballistic lithotripsy devices, and more recently through the use of suction sheaths during PCNL. Intraoperative suction has been introduced as an effective method to remove residual fragments (RFs), thereby reducing the need for manual extraction with baskets.

Suction has also been employed in RIRS, providing multiple advantages including improved stone fragmentation and dusting, enhanced removal of debris and fragments, reduction of intra-renal temperature and pressure, as well as better intraoperative visualization.

In a prospective multicenter trial, Gauhar et al. demonstrated that the flexible and navigable suction ureteral access sheath (FANS-UAS) is safe and effective for use in pediatric RIRS, yielding high stone-free rates with low complication rates. This supports its emerging role as a valuable innovation in pediatric endourological procedures.

The initial experience using a semi-closed-circuit vacuum-assisted mini-percutaneous nephrolithotomy (Mini-PCNL) system in pediatric patients, achieving an 80% stone-free rate with no intraoperative complications and only minor postoperative events. This technique, which integrates continuous irrigation inflow with suction-controlled outflow, was found to be a safe and effective option for managing complex renal stones in children while maintaining acceptable operative times.

研究类型

介入性

注册 (估计的)

72

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

- Renal stone burden 1- 2.5 cm confirmed by imaging (CT or ultrasound).

Exclusion Criteria:

  • Patients who refuse to participate in the study.
  • Untreated Urinary tract infection (UTI) proved by urine culture and sensitivity.
  • Uncorrected coagulopathy.
  • Anatomical anomalies or ureteral stricture precluding either surgical approach.
  • Previous surgical intervention on the same kidney.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Group A(Flexible Ureteroscopy with Flexible Navigable Suction Ureteral Access Sheath )
About 36 pediatric patients suffering from Renal Stones 1- 2.5 cm will be treated by Flexible Ureteroscopy with Flexible Navigable Suction Ureteral Access Sheath
To compare the efficacy and safety of flexible ureteroscopy using a flexible and navigable suction ureteral access sheath (FANS-UAS) versus mini-percutaneous nephrolithotomy (Mini-PCNL) using a vacuum-assisted access sheath (VAAS) in the management of pediatric renal stones 1-2.5 cm
其他名称:
  • Mini-Percutaneous Nephrolithotomy
有源比较器:Group B(Mini-Percutaneous Nephrolithotomy with Vacuum-Assisted Access Sheath )
About 36 pediatric patients suffering from Renal Stones 1- 2.5 cm will be treated by Mini-Percutaneous Nephrolithotomy with Vacuum-Assisted Access Sheath
To compare the efficacy and safety of flexible ureteroscopy using a flexible and navigable suction ureteral access sheath (FANS-UAS) versus mini-percutaneous nephrolithotomy (Mini-PCNL) using a vacuum-assisted access sheath (VAAS) in the management of pediatric renal stones 1-2.5 cm
其他名称:
  • Mini-Percutaneous Nephrolithotomy

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Management of pediatric renal stones
大体时间:6 months
To compare stone-free rate (SFR) at 1 month after the procedure between RIRS using FURS-UAS and mini-PCNL using VASS in pediatric patients with renal stones 1-2.5 cm
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Youssef Mahmoud kotb, Professor、Urology Department, Faculty of Medicine, Ain Shams University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年6月10日

研究注册日期

首次提交

2026年8月9日

首先提交符合 QC 标准的

2026年8月10日

首次发布 (实际的)

2026年8月13日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年8月10日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • Management of Renal Stones

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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