Mini-percutaneous Nephrolithotomy With a Flexible Mini-nephroscope and a Flexible and Navigable Suction Access Sheath for Complex Renal Stones: A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Immediate stone-free rate
研究概览
简要总结
This prospective pilot study aims to evaluate the feasibility, safety, and preliminary clinical outcomes of a novel mini-percutaneous nephrolithotomy (mini-PCNL) technique integrating a flexible mini-nephroscope with a flexible and navigable suction access sheath (FANS) for the treatment of complex renal stones.
Thirty consecutive patients with renal stones ≥2 cm will be prospectively enrolled. All patients will undergo FANS-assisted mini-PCNL. The primary outcome is the immediate stone-free rate assessed by non-contrast CT within 72 hours after surgery. Secondary outcomes include operative parameters, postoperative pain, complications, length of hospital stay, and quality of life.
This pilot study is designed to provide preliminary evidence supporting the feasibility and safety of FANS-assisted mini-PCNL and to inform the design of future larger-scale studies.
详细描述
Conventional mini-PCNL may be limited by restricted access to anatomically challenging calyces and inefficient evacuation of stone fragments when flexible nephroscopy is required.
A novel technique integrating a flexible mini-nephroscope with a flexible and navigable suction access sheath (FANS) has been developed to enable flexible intrarenal navigation combined with active suction during antegrade lithotripsy.
This prospective pilot study will enroll 30 consecutive patients undergoing FANS-assisted mini-PCNL for complex renal stones. The study focuses on feasibility, safety, and preliminary clinical outcomes, including stone clearance and perioperative morbidity. The results will serve as preliminary data for future confirmatory or comparative clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years
- •Patients with renal stones measuring 2 cm or larger in maximum diameter
- •American Society of Anesthesiologists (ASA) physical status classification I-III
- •Planned to undergo mini-percutaneous nephrolithotomy
- •Able and willing to provide written informed consent
排除标准
- •Uncontrolled urinary tract infection at the time of surgery
- •Known bleeding tendency or coagulation disorders
- •Contraindication to general anesthesia
- •Pregnancy or breastfeeding
研究组 & 干预措施
FANS-assisted mini-PCNL
Mini-percutaneous nephrolithotomy performed using a flexible mini-nephroscope combined with a flexible and navigable suction access sheath to facilitate flexible access and active stone fragment evacuation.
干预措施: FANS-assisted mini-percutaneous nephrolithotomy (Procedure)
结局指标
主要结局
Immediate stone-free rate
时间窗: Postoperative day 0 to 3
Absence of residual stones or fragments \>2 mm detected by non-contrast CT
次要结局
- Stone-free rate at 1 month(Postoperative day 30 (±7 days))
- Operative time(From skin puncture to completion of the procedure (intraoperative period))
- Postoperative pain score(Postoperative day 1)
- Postoperative complications(Postoperative day 0 to 30)
- Length of postoperative hospital stay(Postoperative day 0 to postoperative day 14)
- Quality of life score(Baseline and postoperative day 30)
研究者
Guohua Zeng
Vice chairman
The First Affiliated Hospital of Guangzhou Medical University