Modified Mini Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy for the Treatment of Complex Renal Calculi: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,380
- 试验地点
- 1
- 主要终点
- Immediate Stone-Free Rate
研究概览
简要总结
Kidney stones that are large or complex are often treated with percutaneous nephrolithotomy, also called PCNL. Standard PCNL uses a larger access tract and is effective for removing complex kidney stones, but it may be associated with more bleeding, pain, and recovery burden. Modified mini-PCNL uses a smaller access tract and may reduce surgical trauma while maintaining a similar stone clearance rate.
This multicenter randomized trial will compare modified mini-PCNL using a 20 Fr access sheath with standard PCNL using a 24 Fr access sheath in adults with complex renal stones. About 1,380 participants from 8 urology centers will be randomly assigned to receive one of the two procedures. The main purpose of the study is to determine whether modified mini-PCNL is not worse than standard PCNL in achieving stone-free status shortly after surgery. Stone-free status will be assessed by low-dose noncontrast CT within 72 hours after surgery. The study will also compare stone-free status at 3 months, complications, operation time, length of hospital stay, need for additional procedures, and quality of life.
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
- Single (Outcomes Assessor)
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
- •Adults aged ≥18 years.
- •Serum creatinine ≤133 μmol/L.
- •American Society of Anesthesiologists (ASA) physical status classification I-III.
- •S.T.O.N.E. score ≥
- •Complex renal stones confirmed by noncontrast computed tomography, including stone surface area >1500 mm², multiple calyceal stones, partial or complete staghorn calculi, or complex anatomical conditions.
- •Patients who provide written informed consent and agree to undergo either modified mini-percutaneous nephrolithotomy or standard percutaneous nephrolithotomy.
排除标准
- •Solitary kidney.
- •Morbid obesity (body mass index ≥35 kg/m²).
- •Previous renal transplantation or urinary diversion.
- •Congenital abnormalities of the urinary tract.
- •Uncorrected coagulopathy.
- •Active urinary tract infection.
研究组 & 干预措施
Modified Mini-PCNL
Participants randomized to this arm will undergo 20 Fr modified mini percutaneous nephrolithotomy using the F17 Hawk nephroscope for the treatment of complex renal stones.
干预措施: 20 Fr Modified Mini Percutaneous Nephrolithotomy (Procedure)
Standard PCNL
Participants randomized to this arm will undergo 24 Fr standard percutaneous nephrolithotomy using the F20.8 Wolf nephroscope for the treatment of complex renal stones.
干预措施: 24 Fr Standard Percutaneous Nephrolithotomy (Procedure)
结局指标
主要结局
Immediate Stone-Free Rate
时间窗: Within 72 hours after surgery
Proportion of participants who achieve stone-free status after surgery. Stone-free status is defined as no residual stone visualized under endoscopy and no residual stone fragments, or residual fragments ≤2 mm, on low-dose noncontrast CT with 2-mm slice thickness.
次要结局
- Stone-Free Rate at 3 Months(3 months after surgery)
- Length of Hospital Stay(From surgery to hospital discharge, assessed up to 30 days after surgery)
研究者
Yongda Liu
Professor and Director, Department of Urology
The First Affiliated Hospital of Guangzhou Medical University