Suction Mini-Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy for the Management of 2-4 cm Kidney Stones: Study Protocol for an International, Multicenter, Parallel-group, Noninferiority, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 960
- 试验地点
- 1
- 主要终点
- Stone free rate (SFR)
研究概览
简要总结
Percutaneous nephrolithotomy (PCNL) is recommended as the first-line treatment choice for kidney stones larger than 2cm in international guidelines . However, tract-related complications affecting renal parenchymal and blood vessels have always been a concern . The mini-PCNL technique which uses a smaller tract (≤18 Fr) has been introduced to decrease tract-related complications . Nevertheless, the smaller mini-PCNL tract necessitates fragmentationi of stones into smaller pieces before extraction, potentially prolonging the operative time. Additionally, higher pressure irrigation is often required to flush out fragments by vacuum cleaner effect. If the drainage of irrigation fluid is insufficient via a smaller tract, the intrarenal pressure (IRP) may build up, leading to pyelovenous backflow and infectious complications.
Suction application in mini-PCNL has the potential to enhance stone fragments removal efficiency, maintain low IRP, and decrease potential postoperative infection complications. In the pre-suction era, mini-PCNL achieved noninferior stone-free rates (SFR) and operative times compared to standard PCNL, along with benefits of reduced bleeding, less postoperative pain, and shorter hospital stay. However, high-level evidence regarding whether suction mini-PCNL can attain comparable outcomes to standard PCNL is still lacking.
Therefore, we have designed this multicenter, international, randomized controlled noninferiority trial comparing suction mini-PCNL with standard PCNL in the management of 2-4 cm kidney stones.
详细描述
Study Objectives:
The objective of the present study is to determine whether suction mini-PCNL is noninferior to standard PCNL in terms of surgical efficiency in the management of 2-4 cm kidney stones.
The primary outcomes are the immediate postoperative stone-free rate (SFR) and operative time. Secondary outcomes include the final SFR at 1 month, length of hospital stay, postoperative complications, and quality of life.
Study Overview:
The present study is an international, multicenter, prospective, parallel group, noninferiority, randomized controlled trial.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Adults aged 18-70 years.
- •American Society of Anesthesiology (ASA) score of 1-
- •Kidney stones measuring 2-4 cm in diameter on non-contrast computer tomography.
- •Ability to provide written informed consent and adhere to trial requirements.
排除标准
- •Anatomy abnormalities, such as urinary diversion, horseshoe kidney, transplanted kidney, or ureteropelvic junction obstruction.
- •Untreated acute urinary tract infection (UTI).
- •Patients on anticoagulant/antithrombotic therapy, or with uncorrected coagulopathies.
- •Patients who decline trial enrolment or cannot adhere to trial requirements.
研究组 & 干预措施
Patients in Group 2 undergo standard percutaneous nephrolithotomy
干预措施: standard percutaneous nephrolithotomy (Procedure)
Patients in Group 1 undergo suction mini percutaneous nephrolithotomy
干预措施: suction mini percutaneous nephrolithotomy (Procedure)
结局指标
主要结局
Stone free rate (SFR)
时间窗: 1 month after removing the pigtail stent
2mm Non-contrast CT is obtained for all patients at one month after removing the pigtail stent to evaluate the final SFR. Stone-free status are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the kidney which were definded as ≤ 4mm, asymptomatic, non-obstructive and non-infectious stone particles.
Operation time
时间窗: the time from puncture to the placement of the nephrostomy tube
Operation time was defined as the time from puncture to the placement of the nephrostomy tube.
Stone free rate (SFR)
时间窗: 72 hours after operation
Immediate postoperative SFR is defined as the absence of residual stone or fragments \<2 mm on low-dose NCCT scan within 72 h after operation.
Operation time
时间窗: the time from percutaneous puncture to completion of double-J or nephrostomy tube placement
Operative time is defined as the time from percutaneous puncture to completion of double-J or nephrostomy tube placement.
次要结局
- Postoperative fever and other complications(intraoperatively or ≤ 1month postoperatively)
- Lithotripsy time(the time for lithotripsy only)
- Final SFR(1 month post intervention)
- Pain VAS score(VAS is evaluated at three time points, namely pre-operatively, post-operatively 6 hours and 24 hours respectively.)
- Length of hospital stay(from the day of surgery to the day of discharge)
- Postoperative complications(up to 1 month post intervention)
- Quality of Life (QoL)(preoperatively and at 1 month postoperatively)
研究者
Guohua Zeng
Vice president
The First Affiliated Hospital of Guangzhou Medical University