Xu Chaojie, Li Aolin, Peng Yiji, Li Lin, Xiong Gengyan, Fan Yu, Zhao Zheng, Li Xin, Zhang Xiaochun, Zheng Yaoyao, Zhang Chi, Lv Changning, Li Xuesong, Wang Gang, Xia Yan, Wang Pu, Yao Lin
Department of Urology, Peking University First Hospital, Beijing.
Department of Urology, The First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, Shenzhen.
Int J Surg. 2025 Jan 1;111(1):661-676. doi: 10.1097/JS9.0000000000002033.
Successful needle puncture of the renal collecting system is a critical but difficult procedure in percutaneous nephrolithotomy (PCNL). Although fluoroscopy and ultrasound are the standard imaging techniques to guide puncture during PCNL, both have known limitations.
To assess the feasibility and safety of a new navigation system for needle puncture in ultrasound-guided PCNL.
This study employed a single-center randomized controlled trial (RCT) design to assess the feasibility and safety of a new navigation system for needle puncture in ultrasound-guided PCNL. Conducted between May 2021 and November 2021, the trial utilized computer-generated random numbers for participant allocation to control for selection bias.
The trial was executed at Department of Urology, Peking University First Hospital in Beijing, China, which serves as an academic medical center.
All patients who met the inclusion criteria were randomly divided into two groups, with 29 patients in each group. One group underwent PCNL procedures using the new navigation system, while the control group underwent standard ultrasound-guided PCNL procedures. Included patients had renal pelvis or caliceal calculi larger than 2.0 cm in diameter or had multiple or staghorn stones. The puncture procedure was performed with the support of real-time ultrasound imaging and visual guidance displayed on the screen.
The primary outcome was system feasibility and puncture success rate. Secondary outcomes included puncture time, total surgical time, number of attempts, postprocedure complications, and 1-year and 3-year stone recurrence rates. Stone clearance was defined by postoperative CT. Descriptive statistics summarized patient demographics, stone size, and location. Independent samples t -tests analyzed puncture time and total surgical time. χ2 or Fisher's exact tests compared stone clearance, complications, socioeconomic status, renal hydronephrosis, stone location, race, and medical history. Linear regression examined the correlation between BMI and puncture time. Significance was set at P <0.05.
For all 58 patients undergoing PCNL, needle punctures of the renal collecting system were completed with a success rate of 100%. The average time from planning the puncture protocol to successful puncture was significantly shorter in the AcuSee guidance system group (3.12 min, range 0.2-6.88 min) compared to the standard ultrasound-guided group (7.58 min, range 5.41-10.68 min), representing a reduction of ~59%. The total surgical time was also shorter in the AcuSee group for patients with no and mild hydronephrosis ( P <0.05). Complication rates were lower in the AcuSee group, with no major complications observed. However, three patients in the standard ultrasound-guided group have adverse effects after the PCNL procedure. The 1-year stone recurrence rate was significantly lower in the AcuSee group (3.4%) compared to the standard group (24.1%), and the 3-year recurrence rate was also lower (6.9% vs. 41.4%). Patient-specific factors such as BMI, renal morphology, and prior surgical history did not significantly affect the performance of the AcuSee system.
The authors report the first clinical application of a new navigation system for needle puncture in ultrasound-guided PCNL. It has been demonstrated that it is feasible and safe compared to the standard ultrasound-guided group in percutaneous renal puncture. This technology provides intuitive and easy-to-use visual guidance, which may facilitate safe, accurate, and fast needle puncture of the kidney.
在经皮肾镜取石术（PCNL）中，成功穿刺肾集合系统是一项关键但困难的操作。尽管荧光透视和超声是PCNL期间引导穿刺的标准成像技术，但两者都存在已知的局限性。
评估一种用于超声引导下PCNL穿刺的新导航系统的可行性和安全性。
本研究采用单中心随机对照试验（RCT）设计，以评估一种用于超声引导下PCNL穿刺的新导航系统的可行性和安全性。该试验于2021年5月至2021年11月进行，利用计算机生成的随机数进行参与者分配，以控制选择偏倚。
该试验在中国北京的北京大学第一医院泌尿外科进行，该科室是一个学术医疗中心。
所有符合纳入标准的患者被随机分为两组，每组29例。一组使用新导航系统进行PCNL手术，而对照组进行标准的超声引导下PCNL手术。纳入的患者患有直径大于2.0 cm的肾盂或肾盏结石，或有多发性或鹿角形结石。穿刺操作在实时超声成像和屏幕上显示的视觉引导支持下进行。
主要结局是系统可行性和穿刺成功率。次要结局包括穿刺时间、总手术时间、尝试次数、术后并发症以及1年和3年结石复发率。结石清除情况通过术后CT确定。描述性统计总结了患者的人口统计学特征、结石大小和位置。独立样本t检验分析穿刺时间和总手术时间。χ²检验或Fisher精确检验比较结石清除情况、并发症、社会经济状况、肾积水、结石位置、种族和病史。线性回归分析体重指数（BMI）与穿刺时间之间的相关性。显著性设定为P<0.05。
对于所有58例行PCNL的患者，肾集合系统的穿刺均成功完成，成功率为100%。与标准超声引导组（7.58分钟，范围5.41 - 10.68分钟）相比，AcuSee引导系统组从规划穿刺方案到成功穿刺的平均时间显著缩短（3.12分钟，范围0.2 - 6.88分钟），减少了约59%。对于无肾积水和轻度肾积水的患者，AcuSee组的总手术时间也更短（P<0.05）。AcuSee组的并发症发生率较低，未观察到重大并发症。然而，标准超声引导组有3例患者在PCNL手术后出现不良反应。AcuSee组的1年结石复发率（3.4%）显著低于标准组（24.1%），3年复发率也较低（6.9%对41.4%）。患者特异性因素，如BMI、肾脏形态和既往手术史，对AcuSee系统的性能没有显著影响。
作者报告了一种用于超声引导下PCNL穿刺的新导航系统的首次临床应用。已证明与标准超声引导组相比，其在经皮肾穿刺中是可行且安全的。该技术提供了直观且易于使用的视觉引导，这可能有助于安全、准确和快速地进行肾脏穿刺。
