NCT06914986尚未招募不适用
A Prospective Multicenter Randomized Controlled Trial of Flexible And Navigable Suction Ureteral Access Sheath Combined With Needle Perc for the Treatment of Partial Staghorn Renal Calculi
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 344
- 主要终点
- stone free rate
研究概览
简要总结
The goal of this clinical trial is to learn if flexible and navigable suction ureteral access sheath combined with needle perc works to treat partial staghorn renal calculi. It will also learn about the safety of drug ABC. The main questions it aims to answer are:
- Does flexible and navigable suction ureteral access sheath combined with needle perc result in similar stone free rate compared with PCNL
- Does flexible and navigable suction ureteral access sheath combined with needle perc result in more complications compared with PCNL Researchers will compare flexible and navigable suction ureteral access sheath combined with needle perc result in similar stone free rate compared with PCNL to see if flexible and navigable suction ureteral access sheath combined with needle perc works to treat partial staghorn renal calculi.
Participants will:
- Performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL
- Visit the clinic after surgery 1 month and 3 month for checkups and tests
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 years
- •CT scan indicates partial staghorn calculi
- •Able to complete the study in accordance with the protocol requirements
- •Informed about the study and has signed the informed consent form
排除标准
- •Severe renal insufficiency (GFR < 30 ml/min/1.73 m²)
- •Significant calyceal hydronephrosis (calyceal width ≥ 2 cm)
- •Renal stone volume > 33.5 cm³
- •Renal stones or nephrocalcinosis caused by genetic diseases or definite metabolic disorders that have not been ruled out, such as renal tubular acidosis, primary hyperoxaluria, primary hyperparathyroidism, etc.
- •Congenital or structural renal abnormalities: spinal deformity, ankylosing spondylitis, horseshoe kidney, medullary sponge kidney, duplicated kidney, polycystic kidney, ectopic kidney, etc.
- •History of previous open renal stone surgery
- •Patients with uncontrolled urinary tract infections
- •Subjects deemed by the investigator to have other factors that make them unsuitable for participation in this trial
研究组 & 干预措施
flexible and navigable suction ureteral access sheath combined with needle perc
Experimental
干预措施: Performed flexible and navigable suction ureteral access sheath combined with needle perc (Procedure)
PCNL group
Other
干预措施: PCNL (Procedure)
结局指标
主要结局
stone free rate
时间窗: 3 month after surgery
Patient will have CT scan 3 month after surgery
次要结局
- complications(3 month after surgery)
研究者
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