Holmium:YAG Laser With MOSES Technology vs Thulium Fiber Laser in Supine Mini-percutaneous Nephrolithotomy With Vacuum-assisted Renal Access Sheath: A Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Stone Lithotripsy time between HoYAG and TFL
研究概览
简要总结
Mini percutaneous nephrolithotripsy is the treatment of choice for kidney stones over 2cm. This procedure commonly uses laser energy for breaking the stones, and among possible laser platforms, Hoyag and thulium fiber laser are FDA approved. Recently, this procedure has also included the use of vacuum assisted renal access sheaths, which allows suction to be employed together with the breaking of stones. This study intends to compare outcomes when using either laser platforms with suction sheaths in participants undergoing mini percutaneous nephrolithotripsy for the treatment of kidney stones.
详细描述
Due to the reduced diameter sheath of miniaturized percutaneous nephrolithotripsy (miniPCNL), surgical outcomes commonly rely on stone fragmentation provided by a laser energy source. Holmium:yttrium-aluminum-garnet laser (HoYAG) has long been considered the gold-standard for lithotripsy, but this position has been challenged by the introduction of the thulium fiber laser (TFL) since its approval for clinical use in 2017. In the same manner, the recently developed ClearPetra™(MicroTech Endoscopy®, China) vacuum-assisted renal access sheath (VA-RAS) is a novel technology that allows for concomitant irrigation and suction during the procedure.
No prior studies to date have exclusively investigated mini-PCNL outcomes with Ho:YAG and TFL when using VA-RAS. This study addresses the literature paucity regarding the outcomes when utilizing the high-power Ho:YAG with MOSES technology vs. TFL in mini-PCNL with VA-RAS. This study hypothesizes that the Ho:YAG may provide more efficient stone clearance, secondary to its superior ability to fragment stones when compared to the TLF laser, which primarily dusts despite the laser settings utilized.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females over 18 years of age
- •Patients with kidney stones, with stone burden larger than 15 mm.
- •Patients undergoing new percutaneous access with primary, supine, unilateral mini-PCNL.
排除标准
- •Simultaneous use of more than 1 laser platform or other form of fragmentation (e.g., ultrasonic).
- •Patients undergoing simultaneous treatment of contralateral kidney stones during the same procedure.
- •Patients undergoing simultaneous treatment of ureteral stones during the same procedure.
- •Pregnant patients.
- •Presence of genitourinary anatomical abnormalities.
- •Uncorrected coagulopathy.
- •External urinary catheters.
- •Immunosuppressed patients.
- •Non-elective procedures.
研究组 & 干预措施
MiniPCNL with HoYAG
In Arm 1, participants will undergo miniPCNL with ClearPetra™ vacuum-assisted ureteral access sheath with HoYAG laser platform. Participants will undergo miniPCNL per standard of care
干预措施: HoYAG laser (Device)
MiniPCNL with TFL
In Arm 2, participants will undergo miniPCNL with ClearPetra™ vacuum-assisted ureteral access sheath with TFL laser platform. Participants will undergo miniPCNL per standard of care
干预措施: TFL laser platform (Device)
结局指标
主要结局
Stone Lithotripsy time between HoYAG and TFL
时间窗: Procedure
Time from scope insertion to scope removal
次要结局
- Total operative time between HoYAG and TFL(Procedure)
- Stone Free Status between ClearPetra and traditional approach(90 days)
- Laser Energy(Procedure)
- Laser Time(Procedure)
研究者
Bristol Whiles, MD
Assistant Professor of Urology
University of Kansas Medical Center