Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones: A Prospective, Randomized, Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 470
- 试验地点
- 2
- 主要终点
- Stone-free rate at 3 months.
研究概览
简要总结
This randomized, parallel-group, non-inferiority trial will compare flexible nephroscopy-assisted single-tract percutaneous nephrolithotomy with conventional multi-tract percutaneous nephrolithotomy in patients with complex unilateral renal stones. The primary outcome is stone-free rate at 3 months, and secondary outcomes include operative time, fluoroscopy time, hemoglobin drop, transfusion rate, hospital stay, complications, need for auxiliary procedures, and cost-effectiveness.
详细描述
This prospective randomized non-inferiority trial will enroll adults aged 18-70 years with complex unilateral renal stones anticipated to require multiple accesses. Participants will be randomized in a 1:1 ratio to either flexible nephroscopy-assisted single-tract PCNL or conventional multi-tract PCNL. The study aims to determine whether the single-tract approach is not inferior to the multi-tract approach with respect to stone-free rate at 3 months, while potentially reducing perioperative morbidity, including bleeding, transfusion, operative time, and length of hospital stay. Secondary analyses will evaluate complication profiles using Clavien-Dindo classification, need for auxiliary procedures, cost-effectiveness, and the predictive value of Guy's Stone Score and S.T.O.N.E. score.
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
- •Age 18-70 years.
- •Unilateral complex renal stones defined by one or more of the following: Guy's Stone Score III-IV, S.T.O.N.E. score ≥9, staghorn or partial staghorn calculus, or stones involving at least 3 calyces on NCCT.
- •Preoperative expectation of multiple accesses by the surgeon.
- •Written informed consent.
排除标准
- •Solitary kidney.
- •Uncorrected coagulopathy.
- •Active urinary tract infection.
- •ASA grade IV or higher.
- •Previous ipsilateral PCNL or open renal surgery.
- •Stones less than 2 cm or simple calyceal stones.
- •Refusal or inability to comply with follow-up.
研究组 & 干预措施
Flexible Nephroscopy-Assisted Single-Tract PCNL
Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed.
干预措施: Flexible Nephroscopy-Assisted Single-Tract PCNL (Procedure)
Conventional Multi-Tract PCNL
Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.
干预措施: Conventional Multi-Tract PCNL (Procedure)
结局指标
主要结局
Stone-free rate at 3 months.
时间窗: 3 months after surgery.
Proportion of patients with no residual stone fragments greater than 4 mm on non-contrast CT.
次要结局
- Transfusion rate(Perioperative/Periprocedural)
- Duration of Postoperative Hospitalization(From the date of PCNL surgery until hospital discharge.)
- Complication rate(Up to 3 months)
- Operative time(Intraoperative)
- Fluoroscopy time(Intraoperative)
- Number of tracts(Intraoperative)
- Hemoglobin drop(From baseline to postoperative day 1.)
研究者
Abul-fotouh Ahmed
Professor of Urology
Al-Azhar University