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机器人辅助部分肾切除术与标准腹腔镜部分肾切除术治疗肾门肿瘤:一项前瞻性多机构研究。

Robot-assisted partial nephrectomy versus standard laparoscopic partial nephrectomy for renal hilar tumor: A prospective multi-institutional study.

机构信息

Department of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.

Department of Urology, Fujita Health University, Toyoake, Japan.

出版信息

Int J Urol. 2021 Apr;28(4):382-389. doi: 10.1111/iju.14469. Epub 2020 Dec 26.

Abstract

OBJECTIVE

To investigate whether robot-assisted partial nephrectomy compared with laparoscopic partial nephrectomy is effective for renal hilar tumor removal.

METHODS

This was a prospective, multicenter, single-arm, open-label trial with a 2-year enrollment period. A total of 22 academic hospitals in Japan participated in the present study. Comparison with historical control values from reported studies of laparoscopic partial nephrectomy was carried out. The warm ischemia time and positive surgical margin rate were set as primary perioperative and oncological outcomes. In the historical control group, these were 27.7 min and 13%, respectively.

RESULTS

The analysis population included 105 participants. The mean warm ischemia time was 20.2 (95% confidence interval 16.7-21.8; P < 0.0001 vs 27.7). Two of 103 participants (1.9%) had a positive surgical margin (95% confidence interval 0.5-6.8%). Both results satisfy the prespecified decision criteria for the superiority of robot-assisted partial nephrectomy over the historical control of laparoscopic partial nephrectomy. Resected weight and preoperative estimated glomerular filtration rate were predictive factors of functional loss of the partially nephrectomized kidney after robot-assisted partial nephrectomy.

CONCLUSION

Robot-assisted partial nephrectomy for clinical T1 renal hilar tumors results in shorter warm ischemia time than and comparable positive surgical margin rate to those reported for laparoscopic partial nephrectomy.

摘要

目的

探讨机器人辅助部分肾切除术与腹腔镜部分肾切除术相比,是否更有利于肾门肿瘤的切除。

方法

这是一项前瞻性、多中心、单臂、开放标签试验,招募期为 2 年。日本共有 22 家学术医院参与了本研究。与腹腔镜部分肾切除术的历史对照研究报告中的值进行比较。主要围手术期和肿瘤学结果为热缺血时间和阳性手术切缘率。在历史对照组中,这两个指标分别为 27.7 分钟和 13%。

结果

分析人群包括 105 名参与者。平均热缺血时间为 20.2 分钟(95%置信区间为 16.7-21.8;P<0.0001 比 27.7)。103 名参与者中有 2 名(1.9%)有阳性手术切缘(95%置信区间为 0.5-6.8%)。这两个结果均满足机器人辅助部分肾切除术优于腹腔镜部分肾切除术的历史对照的预设优越性决策标准。切除重量和术前估计肾小球滤过率是机器人辅助部分肾切除术后部分肾切除肾功能丧失的预测因素。

结论

机器人辅助部分肾切除术治疗临床 T1 肾门肿瘤,热缺血时间短于腹腔镜部分肾切除术,阳性手术切缘率与腹腔镜部分肾切除术报告的相似。

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