Prospective, Multicenter, Randomized Controlled Trial of Super Pulse Thulium Fiber Laser Combined With Flexible Negative Pressure Suction Sheath Versus Conventional Sheath for the Treatment of Kidney Stones
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 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 the combination of super pulsed thulium fiber laser (sTFL) with a flexible negative pressure suction sheath is more effective and safer than sTFL with a conventional sheath in treating kidney stones and/or ureteral stones. The main questions it aims to answer are:
Does the sTFL with a flexible negative pressure suction sheath have a higher stone - free rate than the sTFL with a conventional sheath? Does the sTFL with a flexible negative pressure suction sheath have fewer complications than the sTFL with a conventional sheath?
Researchers will compare the two treatment groups to see if there are differences in stone - free rate and complication rates.
Participants will:
Undergo ureteroscopic lithotripsy surgery. In the experimental group, have a flexible negative pressure suction sheath inserted along a guidewire to the stone site under general anesthesia, then have a ureteroscope inserted through the sheath to the stone site, and have the stone fragmented by sTFL with a power setting of 0.8J and a frequency of 12 - 20Hz while the fragments are removed by negative pressure suction.
In the control group, have a conventional sheath inserted to the upper ureter or the ureteropelvic junction under general anesthesia, then have a ureteroscope inserted through the sheath to the stone site, and have the stone fragmented by sTFL with a power setting of 0.8J and a frequency of 12 - 20Hz and the fragments removed by a stone basket.
详细描述
This is a prospective, multicenter, randomized, controlled clinical trial aimed at comparing the efficacy and safety of super pulsed thulium fiber laser (sTFL) combined with a flexible negative pressure suction sheath versus sTFL combined with a conventional sheath in the treatment of kidney stones and/or ureteral stones.
- Background and Rationale Urinary calculi are common, with a significant recurrence rate. Incomplete stone removal during treatment is a contributing factor to recurrence. The flexible negative pressure suction sheath offers potential advantages over the conventional sheath, and when combined with the high-performance sTFL, may provide better treatment outcomes. However, a clinical comparison of these combinations has been lacking.
- Study Design
Multicenter: Involving hospitals such as Shanghai Jiao Tong University School of Medicine Affiliated First People's Hospital, Shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People's Hospital, and Weifang Hospital of Traditional Chinese Medicine.
Randomization: Simple randomization is used, with a 1:1 ratio of participants assigned to the experimental group (sTFL + flexible negative pressure suction sheath) and the control group (sTFL + conventional sheath) via a central randomization system.
Blinding: A third-party independent assessment method is employed. Two radiologists blinded to the patient's group and clinical information will evaluate the CT scans at 3 months postoperatively to determine the stone - free rate. 3. Participants
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 years old.
- •Diagnosed with kidney stones and/or ureteral stones, and stone diameter is ≥6mm and ≤20mm
- •Plan to undergo fURS lithotripsy
- •General anesthesia to complete the operation
- •The latest urine culture before surgery is negative
- •Signed and dated informed consent
排除标准
- •Isolated kidney
- •Previous history of kidney transplantation or urinary diversion surgery
- •Congenital malformations of urinary system
- •Abnormal coagulation mechanism due to blood system diseases, liver diseases, etc
- •Severe heart or lung disease, malignancy and immune deficiency status
- •Neurogenic bladder
- •Failure to provide informed consent
- •Have an untreated urinary tract infection
- •The presence of known anatomic abnormalities (such as ureteral stenosis), urothelial tumors, or stones that can be removed directly without the use of laser lithotripsy
- •Pregnant women
- •In cases where the stone cannot be reached with a bendable negative pressure suction sheath, or in cases where the stone cannot be reached with a conventional sheath or the pyeloureteral junction
- •Epidural anesthesia or lumbar anesthesia to complete the operation
结局指标
主要结局
Stone free rate
时间窗: 3 months postoperatively
The proportion of patients with no residual stone or with residual stone diameter less than 2mm, as determined by non - contrast CT scan. This measure is used to evaluate the effectiveness of the two treatment methods in completely removing the stones.
次要结局
- time of operation(During the surgical procedure)
- Complication(During the surgical procedure and within 24 hours after the surgical procedure)
研究者
Yi Shao
Director
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine