跳至主要内容
临床试验/NCT07193940
NCT07193940尚未招募不适用

Flexible Ureteroscopy Versus Extracorporeal Shock Wave Lithotripsy for Treatment of Lower Calyceal Renal Stones Less Than 15 mm: A Prospective Randomized Comparative Study

Assiut University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年10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
尚未招募
入组人数
70
试验地点
1
主要终点
Stone-free rate at 1 months on low-dose NCCT (no fragment >2 mm; report CIRF separately)

研究概览

简要总结

To compare the efficacy and safety of flexible ureterorenoscopy (fURS) versus extracorporeal shock wave lithotripsy (ESWL) in managing lower calyceal renal stones ≤15 mm and <1000 HU.

详细描述

Urolithiasis is a common condition with a steadily increasing global prevalence, and lower calyceal stone treatment is particularly challenging. While stones ≤15 mm and <1000 Hounsfield Units (HU) are generally treatable, lower pole anatomy limits fragment clearance after extracorporeal shock wave lithotripsy (ESWL). Published SFR for ESWL in this location range between 60-80%, which are lower compared to other calyceal sites. Predictive factors such as stone density, size, and skin-to-stone distance are applied to optimize patients selection.

Conversely, flexible ureteroscopy (fURS) with laser lithotripsy achieves more and higher quality SFRs (80-95%) by active fragmentation and retrieval of the stones, thereby bypassing the anatomic barriers. However, It is invasive, requires anesthesia and has complications such as ureteral trauma and infection, including a small but certain risk of sepsis. EAU and AUA guidelines currently recommend either ESWL or URS for stones <20 mm, but note reduced clearance of lower-pole stones by ESWL.

This creates a therapeutic dilemma: should stones ≤15 mm and <1000 HU, theoretically ideal for ESWL, nevertheless to be managed non-invasively, or should fURS be given priority because of increased reliability? We anticipate that fURS will provide a higher 3-month stone-free rate than ESWL, though ESWL may remain a suitable first-line treatment in well-selected patients owing to lower morbidity and non-invasive nature.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults (≥18 y)
  • •Lower-calyx stone
  • •Less than or equal15 mm
  • •Mean Hounsfield (HU) <1000

排除标准

  • •Pregnancy
  • •Uncorrected coagulopathy
  • •Active UTI/obstruction
  • •Anatomical barriers to Flexible Ureteroscopy or extracorporeal shock wave lithotripsy coupling (e.g., prohibitive SSD/BMI).
  • •Cardiac devices contraindicating ESWL

研究组 & 干预措施

Flexible Ureteroscopy

Experimental

Interventional procedure: Flexible Ureteroscopy

干预措施: Flexible Ureteroscopy (Procedure)

Extracorporeal Shock Wave Lithotripsy

Experimental

Extracorporeal Shock Wave Lithotripsy (ESWL)

干预措施: extracorporeal shock wave lithotripsy (ESWL) (Procedure)

结局指标

主要结局

Stone-free rate at 1 months on low-dose NCCT (no fragment >2 mm; report CIRF separately)

时间窗: baseline

Stone-free rate at 1 months on low-dose NCCT (no fragment \>2 mm; report CIRF separately)

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

Ahmed Atef Mohamed Abdellatif

Dr

Assiut University

研究点 (1)

Loading locations...

相似试验

Flexible Ureteroscopy Versus Extracorporeal Shock... | 临床试验