机器人辅助肾门肿瘤部分肾切除术的长期随访：一项前瞻性多机构研究（ROBOHIT试验）

Extended Follow-Up of Robot-Assisted Partial Nephrectomy for Renal Hilar Tumor: A Prospective Multi-Institutional Study (ROBOHIT Trial).

作者信息

Teishima Jun, Shiroki Ryoichi, Takagi Toshio, Eto Masatoshi, Morizane Shuichi, Yamasaki Toshinari, Kohjimoto Yasuo, Hongo Fumiya, Tsujino Takuya, Bekku Kensuke, Hinata Nobuyuki, Okada Atsushi, Yoshida Tetsuya, Kondo Tsunenori, Kawamorita Naoki, Yamamoto Hayato, Isotani Shuji, Shimbo Masaki, Nagayama Jun, Yamaguchi Kunihisa, Kinoshita Hidefumi, Miyake Hideaki

机构信息

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

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

出版信息

Int J Urol. 2025 Sep;32(9):1165-1171. doi: 10.1111/iju.70116. Epub 2025 May 19.

DOI:10.1111/iju.70116

PMID:40387294

Abstract

OBJECTIVES

We aimed to evaluate the long-term oncological and functional outcomes after robot-assisted partial nephrectomy (RAPN) for renal hilar tumors.

METHODS

A total of 22 academic hospitals in Japan participated in a prospective, multicenter, single-arm, open-label trial with a 2-year enrollment period. After undergoing RAPN, 105 patients with clinical T1 renal hilar tumors were followed up for 5 years and evaluated. Recurrence-free survival, overall survival, and trends of renal function were set as oncological and functional outcomes.

RESULTS

Five-year overall survival and recurrence-free survival were 98.0% and 89.2%, respectively. Mean estimated glomerular filtration rates (eGFRs) were 69.031 mL/min preoperatively, and were 59.374, 58.334, 58.221, 56.975, and 59.602 mL/min at 1, 2, 3, 4, and 5 years after surgery, respectively. While eGFR was significantly lower than the preoperative one at all points (p < 0.001), eGFRs at 1 and 5 years after surgery did not differ significantly (p = 0.793).

CONCLUSION

After long-term follow-up, RAPN for clinical T1 renal hilar tumors continues to provide functional and oncological outcomes equivalent to those in the perioperative period.

TRIAL REGISTRATION

The study protocol was registered in the Japan Registry of Clinical Trials (jRCT1052190005, UMIN000023968).

摘要

目的

我们旨在评估机器人辅助部分肾切除术（RAPN）治疗肾门肿瘤后的长期肿瘤学和功能结局。

方法

日本共有22家学术医院参与了一项前瞻性、多中心、单臂、开放标签试验，入组期为2年。105例临床T1期肾门肿瘤患者接受RAPN治疗后，进行了5年的随访和评估。无复发生存率、总生存率以及肾功能趋势被设定为肿瘤学和功能结局。

结果

5年总生存率和无复发生存率分别为98.0%和89.2%。术前平均估计肾小球滤过率（eGFR）为69.031 mL/min，术后1、2、3、4和5年分别为59.374、58.334、58.221、56.975和59.602 mL/min。虽然各时间点的eGFR均显著低于术前（p < 0.001），但术后1年和5年的eGFR无显著差异（p = 0.793）。