A Randomized, Single-Blind Clinical Trial Comparing Robotic-Assisted Fluoroscopic-Guided with Ultrasound-Guided Renal Access for Percutaneous Nephrolithotomy
A Randomized, Single-Blind Clinical Trial Comparing Robotic-Assisted Fluoroscopic-Guided with Ultrasound-Guided Renal Access for Percutaneous Nephrolithotomy
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DOI：
10.1097/ju.0000000000002749
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发表时间：
2022-09-01
影响因子：
6.6
通讯作者：
Yasui, Takahiro
中科院分区：
文献类型：
--
作者：
Taguchi, Kazumi;Hamamoto, Shuzo;Yasui, Takahiro
目的：我们进行了一项随机、单盲临床试验，比较机器人辅助透视引导(RAF组)和超声引导(US组)肾通路在微创经皮肾取石术(PCNL)中的手术效果。材料和方法：我们收集了2020年1月至2021年5月在输尿管镜辅助下微创经皮肾取石术治疗巨大肾结石的患者。使用在线软件进行区组随机化。在RAF组中，使用带X线的自动针靶进行透视引导下的肾通路。采用16.5Fr/17.5Fr腔内气压弹道碎石术。结果：共纳入71例患者(US组35例，RAF组36例)。US组和RAF组单次穿刺率分别为34.3%和50.0%，差异无统计学意义(p=0.2)。在美国组中有14.3%的病例与皇家空军组中没有病例相比，居民由于难以定向而无法获得访问权限(p=0.025)。RAF组平均针刺次数明显少于对照组(1.83vs2.51次，p=0.025；5.5min vs8.0min，p=0.049)。术后3个月结石排净率：RAF组为83.3%，US组为70.6%(P=0.26)。多因素分析显示，RAF引导下平均穿刺量减少0.73次(p=0.021)。结论：RAF肾通路在微创经皮肾镜取石术中有潜在的应用前景。
Purpose: We conducted a randomized, single-blind clinical trial comparing the surgical outcomes of robotic-assisted fluoroscopic-guided (RAF group) and ultrasound-guided (US group) renal access in mini-percutaneous nephrolithotomy (PCNL).Materials and Methods: We recruited patients who underwent mini-PCNL with ureteroscopic assistance for large renal stones between January 2020 and May 2021. Block randomization was performed using online software. Automated needle target with x-ray was used for fluoroscopic-guided renal access in the RAF group. PCNL was performed by residents using a pneumatic lithotripsy system with 16.5Fr/17.5Fr tracts. The primary outcome was single puncture success, and the secondary outcomes were stone-free rate, complication rate, parameters measured during renal access and fluoroscopy time.Results: In total, 71 patients (35 in US group, 36 in RAF group) were enrolled. No difference was seen in the single puncture success rate between the US and RAF groups (34.3% and 50.0%, p=0.2). In 14.3% cases in the US group vs no cases in the RAF group, the resident was unable to obtain access due to difficult targeting (p=0.025). The mean number of needle punctures was significantly fewer, and the median duration of needle puncture was shorter in the RAF group (1.83 vs 2.51 times, p=0.025; 5.5 vs 8.0 minutes, p=0.049, respectively). The stone-free rate at 3 months after surgery was 83.3% and 70.6% in the RAF and US groups, respectively (p=0.26). Multivariate analysis revealed that RAF guidance reduced the mean number of needle punctures by 0.73 times (p=0.021).Conclusions: RAF renal access in mini-PCNL may have further potential applications in this field.