Flexible Ureteroscopy Versus Extracorporeal Shock Wave Lithotripsy for Treatment of Lower Calyceal Renal Stones Less Than 15 mm: A Prospective Randomized Comparative Study
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
Interventional procedure: Flexible Ureteroscopy
干预措施: Flexible Ureteroscopy (Procedure)
Extracorporeal Shock Wave Lithotripsy
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
Ahmed Atef Mohamed Abdellatif
Dr
Assiut University
