Ho:YAG Laser Versus Thulium Laser for the Management of 2-4cm Kidney Stones During SMP(Suction Mini Percutaneous Nephrolithotomy):An International Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 682
- 试验地点
- 1
- 主要终点
- Operation time
研究概览
简要总结
With the rapid development of medical equipment and the increasing experience, minimally invasive percutaneous nephrolithotomy (mini-PCNL) has been a well established modality for the management of upper urinary tract stones. The introduction of negative pressure suction technology into mini-PCNL can actively suck out the perfusion fluid and stone fragments, therefore to speed up stone removal efficency and keep a low intrarenal pressure, and was called suction mini-PCNL (SMP).
The common energy sources for SMP were pneumatic ballistic lithotripsy and Ho:YAG laser. The handle of pneumatic ballistic lithotripsy was heavy and can not be fixed on the nephroscope, furthermore, the fragments in pneumatic ballistic lithotripsy was large, therefore the active suction and discharge of stone fragments can not be well completed at the same time of lithotripsy. However, the Ho:YAG laser can well match the requirement of SMP that lithotripsy and suction can work at the same time. Recently, thulium fiber laser (TFL) was also used for lithotripsy. The versatility of TFL, including high frequencies and reduced retropulsion may result in higher ablation efficiency compared to Ho:YAG laser. However, there is no clinical study on the difference between Ho:YAG laser and thulium laser in SMP, which limits the reasonable choice of laser in SMP to a certain extent.
So, the investigators would like to have an international multi-centre RCT to compare the therapeutic effects of SMP with Ho:YAG laser versus TFL in the treatment of 2-4cm renal calculi, so as to provide high-level evidence to support for clinical selection.
详细描述
To compare the therapeutic effects of SMP with Ho:YAG laser versus TFL in the treatment of 2-4cm renal calculi,an international multi-centre RCT was conducted with the comparision of Ho:YAG laser and Thulium laser . Investigators plan to do an international multi-centre randomized controlled trial (RCT).
There are 20 hospitals from China, USA, United Kingdom, Italy, Spain, Sweden, Kuwait, Turkey, Philippines, Bulgaria and others.
The primary study endpoints was operation time,while the secondary study endpoints were stone free rate (SFR), postoperative hemoglobin drop, blood transfusion, postoperative fever and other complications.
This study will be started at March,2022 and ended at December,2024.
According to the literature and unpublished data from clinical practice or trails, the operative time of SMP with Ho:YAG laser and TFL for treating 2-4cm kidney stones was about 50±10.0 and 60±10min. It was assumed that the operation time of SMP using TFL was longer than that of SMP using Ho:YAG laser, the test level Type-1 error (α) was 0.05, the test efficiency power (1-β) was 0.8, the ratio of the two groups of sample size was 1:1, the non-inferiority test threshold was -12, and 310 was calculated for each group. Taking into account disengagement and other problems, n=341 was required in each group, therefore a total of 682 cases were required in the present RCT.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2-4cm kidney stones.
- •Aged 18-70 years.
- •SMP with Ho:YAG laser or TFL.
排除标准
- •Transplanted kidney, solitary kidney, horseshoe kidney, urinary diversion, urethra deformity and other special cases.
- •If empyema was found during SMP, the nephrostomy tube was retained and the patient was excluded from the trail.
结局指标
主要结局
Operation time
时间窗: Intraoperative (the time from puncture to the placement of the nephrostomy tube)
Operation time is defined as the time from puncture to the placement of the nephrostomy tube
次要结局
- Complications is defined as any adverse event occurred(intraoperatively or ≤ 1month postoperatively)
- Stone free rate (SFR)(1 month after removing the pigtail stent)
- postoperative fever(≤ 1month postoperatively)
研究者
Guohua Zeng
Vice president
The First Affiliated Hospital of Guangzhou Medical University
