Department of Urology, Graduate School of Biomedical and Health Sciences Hiroshima University, 1-2-3, Kasumi Minami-ku, Hiroshima, 734-8551, Japan.
Department of Urology, Kobe University Graduate School of Medicine, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 657-0017, Japan.
Int J Clin Oncol. 2024 Oct;29(10):1548-1556. doi: 10.1007/s10147-024-02599-9. Epub 2024 Aug 7.
This study aimed to compare the efficacy of robot-assisted partial nephrectomy for completely endophytic renal tumors with the reported outcomes of conventional laparoscopic partial nephrectomy and investigate the transition of renal function after robot-assisted partial nephrectomy.
We conducted a prospective, multicenter, single-arm, open-label trial across 17 academic centers in Japan. Patients with endophytic renal tumors classified as cT1, cN0, cM0 were included and underwent robot-assisted partial nephrectomy. We defined two primary outcomes to assess functional and oncological aspects of the procedure, which were represented by the warm ischemic time and positive surgical margin, respectively. Comparisons were made using control values previously reported in laparoscopic partial nephrectomy studies. In the historical control group, the warm ischemia time was 25.2, and the positive surgical margin was 13%.
Our per-protocol analysis included 98 participants. The mean warm ischemic time was 20.3 min (99% confidence interval 18.3-22.3; p < 0.0001 vs. 25.2). None of the 98 participants had a positive surgical margin (99% confidence interval 0-5.3%; p < 0.0001 vs. 13.0%). The renal function ratio of eGFR before and after protocol treatment multiplied by splits was 0.70 (95% confidence interval: 0.66-0.75). Factors such as preoperative eGFR, resected weight, and warm ischemic time influenced the functional loss of the partially nephrectomized kidney after robot-assisted partial nephrectomy.
Robot-assisted partial nephrectomy for completely endophytic renal tumors offers a shorter warm ischemia time and comparable positive surgical margin rate compared with conventional laparoscopic partial nephrectomy.
本研究旨在比较机器人辅助部分肾切除术治疗完全内生性肾肿瘤的疗效与传统腹腔镜部分肾切除术的报道结果,并探讨机器人辅助部分肾切除术后肾功能的变化。
我们在日本的 17 个学术中心进行了一项前瞻性、多中心、单臂、开放标签的试验。纳入内生性肾肿瘤 cT1、cN0、cM0 患者,行机器人辅助部分肾切除术。我们定义了两个主要结局来评估手术的功能和肿瘤学方面,分别代表热缺血时间和阳性手术切缘。比较使用腹腔镜部分肾切除术研究中报告的对照值。在历史对照组中,热缺血时间为 25.2,阳性手术切缘为 13%。
我们的方案分析包括 98 名参与者。平均热缺血时间为 20.3 分钟(99%置信区间为 18.3-22.3;p<0.0001 与 25.2 相比)。98 名参与者中均无阳性手术切缘(99%置信区间为 0-5.3%;p<0.0001 与 13.0%相比)。协议治疗前后 eGFR 的比值乘以劈开的肾单位为 0.70(95%置信区间:0.66-0.75)。术前 eGFR、切除重量和热缺血时间等因素影响机器人辅助部分肾切除术后部分肾切除肾脏的功能丧失。
与传统腹腔镜部分肾切除术相比,机器人辅助部分肾切除术治疗完全内生性肾肿瘤可缩短热缺血时间,且阳性手术切缘率相当。