Optimum Time for Extracorporeal Shock Wave Lithotripsy for Residual Stones After Percutaneous Nephrolithotomy: A Prospective Comparative Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 476
- 试验地点
- 1
- 主要终点
- Stone-Free Rate at 3 Months
研究概览
简要总结
Residual renal stone fragments remain a common clinical issue following percutaneous nephrolithotomy (PCNL), with reported incidence ranging from 10% to 30%. These fragments may act as a nidus for recurrent stone formation, infection, or obstruction, necessitating further intervention. Extracorporeal shock wave lithotripsy (ESWL) is widely used as a non-invasive treatment option for such residual stones; however, the optimal timing of ESWL after PCNL remains unclear.
Early application of ESWL may enhance stone clearance before fragment embedding or encrustation occurs, but it could be associated with increased risk of bleeding or infection due to incomplete renal healing. Conversely, delayed ESWL allows for better tissue recovery but may permit stone growth or persistence of symptoms.
This prospective randomized comparative study aims to evaluate the optimal timing of ESWL after PCNL in patients with residual renal stones ≤15 mm. Eligible patients will be randomized into two groups: early ESWL (within 7-14 days after PCNL) and delayed ESWL (after 3-4 weeks). The primary outcome is the stone-free rate at 3 months, while secondary outcomes include complication rates, pain scores, renal function changes, and the need for additional interventions.
The results of this study are expected to provide evidence-based guidance on the ideal timing of ESWL following PCNL to maximize efficacy and minimize complications.
详细描述
Percutaneous nephrolithotomy (PCNL) is considered the gold standard treatment for large and complex renal stones. Despite advances in surgical techniques and imaging, residual stone fragments (RFs) remain a relatively common finding after PCNL, with reported rates ranging from 10% to 30%. These residual fragments are clinically significant, as they may serve as a nidus for recurrent stone formation, urinary tract infection, obstruction, and the need for secondary interventions.
Extracorporeal shock wave lithotripsy (ESWL) is a widely accepted, non-invasive modality for the management of residual renal stones following PCNL. However, the optimal timing for performing ESWL after PCNL remains controversial. Early ESWL may improve stone clearance rates by targeting fragments before they become embedded within the collecting system or undergo encrustation. On the other hand, early intervention may be associated with an increased risk of complications, such as bleeding or infection, due to incomplete renal parenchymal healing after PCNL.
Delayed ESWL allows for adequate healing of renal tissue, potentially reducing procedure-related complications. However, postponing treatment may allow residual fragments to increase in size, migrate, or become symptomatic, which could negatively impact overall outcomes and increase the likelihood of additional interventions.
Given this clinical uncertainty, this study is designed as a prospective, randomized, comparative clinical trial to evaluate the optimal timing of ESWL after PCNL. Patients who undergo PCNL and are found to have residual renal stones measuring ≤15 mm on postoperative imaging (non-contrast CT or ultrasound) will be considered eligible for inclusion.
Eligible participants will be randomly assigned in a 1:1 ratio into two groups:
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years.
- •Single or multiple residual renal stones ≤15 mm after PCNL.
- •Normal renal function (serum creatinine <1.5 mg/dL).
- •No active UTI.
排除标准
- •Bleeding disorders or anticoagulant therapy.
- •Obstructed drainage or active sepsis.
- •Stones >15 mm or requiring secondary PCNL.
研究组 & 干预措施
(Early ESWL): ESWL within 7-14 days after PCNL
Patients receive extracorporeal shock wave lithotripsy (ESWL) within 7-14 days after percutaneous nephrolithotomy (PCNL) for treatment of residual renal stones ≤15 mm. Standard ESWL protocol is applied with a maximum of 3 sessions.
干预措施: Extracorporeal shock wave lithotripsy (ESWL) (Procedure)
(Delayed ESWL): ESWL after 3-4 weeks.
Patients receive extracorporeal shock wave lithotripsy (ESWL) 3-4 weeks after percutaneous nephrolithotomy (PCNL) for treatment of residual renal stones ≤15 mm. Standard ESWL protocol is applied with a maximum of 3 sessions.
干预措施: Extracorporeal shock wave lithotripsy (ESWL) (Procedure)
结局指标
主要结局
Stone-Free Rate at 3 Months
时间窗: 3 months after ESWL
The proportion of patients who are stone-free, defined as no residual fragments greater than 2 mm on imaging (ultrasound or CT scan) at 3 months after ESWL treatment.
次要结局
- Complication Rate(Within 4 weeks after ESWL)
研究者
Mahmoud Abdallah
lecturer of urology Beni-Suef university hospital
Beni-Suef University