A Multicenter Randomized Trial Comparing FANS-Based Flexible Ureteroscopy Versus Suction Mini-Percutaneous Nephrolithotomy for Renal Stones 2-3 cm. The National Innovative Large Egyptian (NILE) Stone Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 254
- 试验地点
- 10
- 主要终点
- stone-free rate (SFR) at 1 month postoperatively
研究概览
简要总结
This multicenter, prospective, randomized clinical trial compares FANS-assisted flexible ureteroscopy (FURS) with suction-assisted mini-percutaneous nephrolithotomy (mini-PCNL) for the treatment of renal stones measuring 2-3 cm. A total of 280 patients will be enrolled across nine tertiary centers and randomized 1:1 to either technique. The primary endpoint is stone-free rate (SFR) at 1 month, assessed by non-contrast CT. Secondary outcomes include operative time, intraoperative complications, postoperative morbidity (Clavien-Dindo), pain scores, hospital stay, reinterventions, and quality of life (EQ-5D-5L). The study aims to provide the first high-quality head-to-head evidence comparing these two modern suction-enhanced technologies, with the goal of defining the optimal minimally invasive approach for medium-sized renal stones.
详细描述
Aim of the Study
The primary aim of this study is to compare the stone-free rate (SFR) of FANS-assisted flexible ureteroscopy versus suction-assisted mini-percutaneous nephrolithotomy (mini-PCNL) in patients with renal stones measuring 2 to 3 cm. Secondary aims include comparing perioperative outcomes, complication rates, length of hospital stay, and patient-reported quality of life between the two treatment modalities.
Patients and Methods Study Design
This is a prospective, multicenter, randomized, superiority trial. Patients will be recruited from nine high-volume tertiary referral centers. Participants will be randomized in a 1:1ratio to undergo either FANS-based flexible ureteroscopy or suction mini-PCNL using a computer-generated randomization tables, stratified by each center. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes (SNOSE) prepared by an independent person who is not involved in patients' recruitment or treatment. Surgeons and investigators will be blinded to group allocation until the point of intervention.
Ethical Considerations The study protocol will be approved by the Institutional Review Board (IRB) of each participating center. All patients will provide written informed consent before enrollment. The study will be conducted in accordance with the principles of the Declaration of Helsinki.
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
- Single (Outcomes Assessor)
盲法说明
Participants and surgeons are unblinded due to the nature of surgical interventions. However, postoperative imaging and clinical outcome assessment will be performed by blinded independent assessors."
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
- •Adults ≥18 years old.
- •Single or multiple renal stones measuring 2 -3 cm (diagnosed by NCCT).
- •Negative urine culture prior to surgery.
- •Suitable for general/spinal anesthesia.
- •Signed informed consent.
排除标准
- •Active urinary tract infection.
- •Anomalous renal anatomy (e.g., horseshoe kidney).
- •Severe ureteral strictures preventing retrograde access.
- •Coagulopathy or inability to discontinue anticoagulation.
结局指标
主要结局
stone-free rate (SFR) at 1 month postoperatively
时间窗: 1 month postoperatively
. SFR will be evaluated using a spiral non-contrast computed tomography (NCCT) scan performed at 1 month after the procedure. Stone-free status will be categorized as no residual or with residual fragments
次要结局
未报告次要终点