Safety and Efficacy of Antegrade Flexible Ureteroscopy-Assisted Percutaneous Nephrolithotomy for Staghorn Calculi: A Prospective Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 420
- 主要终点
- Immediately stone-free rate (SFR)
研究概览
简要总结
Objective This study aims to evaluate the safety and efficacy of antegrade flexible ureteroscopy-assisted PCNL for the treatment of staghorn calculi, compared with standard PCNL.
Methods This prospective, multicenter, randomized controlled trial plans to enroll 420 patients with staghorn calculi, randomly assigned into two groups: the experimental group (antegrade flexible ureteroscopy-assisted PCNL, n=210) and the control group (standard PCNL, n=210). The primary endpoint is stone-free rate (defined as no residual fragment ≥2 mm on postoperative CT). Secondary endpoints include operative time, number of percutaneous tracts, rate of secondary procedures, hemoglobin decrease, postoperative complications (Clavien-Dindo classification), and length of hospital stay. All patients will undergo CT evaluation on postoperative day 2. Subgroup analysis will be performed according to the number of stone branches (≥5 vs <5).
详细描述
Background Renal calculi are among the most common diseases in urology. Current treatment options include extracorporeal shock wave lithotripsy (ESWL), flexible ureteroscopic lithotripsy, and percutaneous nephrolithotomy (PCNL). For renal stones ≥2 cm, PCNL is the recommended first-line treatment.
However, because of the large stone burden and the involvement of multiple calyces, it is often difficult to achieve complete clearance with a single PCNL session. Excessive angulation of the nephroscope may increase the risk of infundibular tears and bleeding, and stones located in parallel or narrow infundibula may be difficult to access, reducing the one-stage stone-free rate. To improve outcomes, several strategies have been adopted:
Multiple percutaneous tracts: Establishing additional tracts allows access to calyces unreachable from the primary tract and increases stone-free rates. However, this also increases the risks of bleeding, infection, and injury to the kidney or adjacent organs. In addition, expansion of the first tract may cause perirenal hematoma or morphological changes due to urine extravasation, making subsequent punctures more challenging. Multiple tracts also prolong postoperative recovery and increase hospitalization costs. Staged procedures: The first PCNL session removes stones in the renal pelvis and accessible calyces, while residual stones are addressed in a second-stage retrograde ureteroscopy. This reduces the risks compared with multiple tracts, but prolongs the treatment cycle and increases costs. Endoscopic combined intrarenal surgery (ECIRS) with modified patient positions: Positions such as the modified supine split-leg, lateral decubitus, or female-specific "Galdakao-modified supine Valdivia" allow simultaneous use of ureteroscopic and percutaneous approaches. This combines the efficiency of PCNL with the wide access angle of ureteroscopy, reduces the need for repositioning under anesthesia, and facilitates intraoperative monitoring. However, it requires two surgical teams, duplicate equipment, and high coordination, which may prolong operative time.
Previous studies suggest that combining single-tract PCNL with flexible ureteroscopy and holmium laser lithotripsy may be an ideal approach for staghorn stones. While antegrade cystoscopic lithotripsy accommodates thicker fibers and offers faster irrigation and clearer visualization, the larger diameter of the cystoscope limits its passage through the ureter, risking residual fragments. Recently, antegrade flexible ureteroscopy-assisted PCNL has been attempted, but most studies are small retrospective series or case reports. The limited adoption may be due to the high purchase and repair costs of reusable flexible ureteroscopes. The development of single-use ureteroscopes has largely overcome these barriers, providing a foundation for multicenter prospective studies.
Based on this background, a multicenter clinical study of antegrade flexible ureteroscopy-assisted PCNL for staghorn calculi has important clinical value. Our preliminary work showed that when the number of stone branches was ≥5, the need for multiple tracts and staged procedures increased, while operative time was prolonged, hospital stay was longer, and the stone-free rate was reduced. We therefore further compared the efficacy of standard PCNL and antegrade flexible ureteroscopy-assisted PCNL stratified by stone branch number.
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 (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Because of the inherent differences between the two interventions, blinding of patients and surgeons is not feasible. Postoperative imaging (CT) will be evaluated by radiologists blinded to treatment allocation, and clinical outcomes will be assessed by investigators who were not involved in the surgeries and remained unaware of the intervention. In addition, statistical analyses will be conducted in a blinded manner, with analysts kept unaware of group assignments until all analyses and interpretations are completed.
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
- •Staghorn calculi confirmed by non-contrast CT of the urinary system; Age ≥18 years; General condition suitable for surgical treatment; Ability to understand and voluntarily sign the informed consent form.
排除标准
- •Solitary kidney or congenital anomalies (such as horseshoe kidney or ectopic kidney); Patients with severe preoperative pyelonephritis; Patients with psychiatric disorders or unwilling to cooperate; Patients with uncontrolled diabetes or hypertension who cannot tolerate surgery; Patients with coagulation disorders; Patients deemed unsuitable for participation in this trial by the investigator.
结局指标
主要结局
Immediately stone-free rate (SFR)
时间窗: On postoperative day 2, a non-contrast CT of the urinary system will be performed, and the absence of residual fragments larger than 2 mm will be defined as stone-free.
defined as no residual fragment ≥2 mm on postoperative CT
次要结局
- Operative time(From the establishment of the first percutaneous renal tract to the placement of the final nephrostomy tube.)
- Duration of hospital stay(Up to 3 months.)
- Complications(Up to 3 months.)
