Department of Urology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University, Nanjing, China.
Department of Pathology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.
Eur Urol Oncol. 2024 Apr;7(2):275-281. doi: 10.1016/j.euo.2023.07.019. Epub 2023 Aug 18.
Although partial nephrectomy has become the gold standard for T1 renal tumors whenever technically feasible, simple enucleation has shown superior results. To the best of our knowledge, no randomized controlled trials comparing these two surgical approaches have been published.
To compare the surgical margin status for robot-assisted simple enucleation (RASE) and standard robot-assisted partial nephrectomy (sRAPN) for clinical T1 renal tumors.
DESIGN, SETTING, AND PARTICIPANTS: This is a prospective, randomized, controlled, noninferiority trial. A total of 380 patients aged 18-80 yr with newly diagnosed, sporadic, unilateral clinical T1 renal tumors (RENAL score <10) were enrolled and randomized to RASE or sRAPN. The primary endpoint was the positive surgical margin (PSM) rate, with a noninferiority margin of 7.5% set. The study was registered on ClinicalTrials.gov (NCT03624673).
We defined noninferiority for RASE versus standard RAPN as an upper 95% confidence interval (CI) bound of <7.5% for the difference in the proportion of patients with a PSM.
A cohort of 380 patients was enrolled and randomly assigned to RASE (n = 190) or sRAPN (n = 190). On intention-to-treat analysis for patients with malignant tumors, 2.3% of patients in the RASE group and 3.0% in the sRAPN group had a PSM. The RASE group showed noninferiority to the sRAPN group within a 7.5% margin (difference -0.7%, 95% CI -4.0% to 2.7%). Per-protocol analysis also demonstrated noninferiority of RASE. The RASE group had a shorter median operative time (145 vs 155 min; p = 0.018) and a lower rate of tumor bed suturing (8.9% vs 43%; p < 0.001) in comparison to the sRAPN group. Estimated blood loss was considerably lower in the sRAPN group than in the RASE group (p = 0.046). The rate of recurrence did not differ between the groups (p > 0.9).
RASE for the management of low- to intermediate-complexity tumors is noninferior to sRAPN in terms of the PSM rate. Long-term follow-up is needed to draw conclusions regarding oncological outcomes.
We carried out a trial to compare simple tumor enucleation versus partial nephrectomy for renal tumors. The outcome we assessed was the proportion of patients with a positive surgical margin. Our results show that simple tumor enucleation is not inferior to partial nephrectomy for this outcome. Longer follow-up is needed to assess other cancer control outcomes.
尽管部分肾切除术已成为技术上可行的 T1 肾肿瘤的金标准，但单纯的肾肿瘤剜除术显示出了更好的效果。据我们所知，目前还没有比较这两种手术方法的随机对照试验。
比较机器人辅助单纯肾肿瘤剜除术（RASE）和标准机器人辅助部分肾切除术（sRAPN）治疗临床 T1 肾肿瘤的手术切缘状态。
设计、设置和参与者：这是一项前瞻性、随机、对照、非劣效性试验。共纳入 380 例年龄 18-80 岁、新诊断、散发性、单侧临床 T1 肾肿瘤（RENAL 评分<10）患者，并随机分为 RASE 或 sRAPN 组。主要终点是阳性手术切缘（PSM）率，设定的非劣效性边界为 7.5%。该研究在 ClinicalTrials.gov 上注册（NCT03624673）。
我们将 RASE 与标准 RAPN 的非劣效性定义为在 PSM 患者比例方面，95%置信区间（CI）上限<7.5%。
共纳入 380 例患者，并随机分为 RASE（n=190）或 sRAPN（n=190）组。在对恶性肿瘤患者的意向治疗分析中，RASE 组和 sRAPN 组的 PSM 发生率分别为 2.3%和 3.0%。RASE 组在 7.5%的边界内表现出非劣效性（差异-0.7%，95%CI-4.0%至 2.7%）。方案分析也表明 RASE 具有非劣效性。RASE 组的中位手术时间更短（145 分钟 vs 155 分钟；p=0.018），肿瘤床缝合率更低（8.9% vs 43%；p<0.001）。与 RASE 组相比，sRAPN 组的估计失血量明显较低（p=0.046）。两组的复发率无差异（p>0.9）。
对于低到中复杂性肿瘤，RASE 在 PSM 率方面不劣于 sRAPN。需要进行长期随访以得出关于肿瘤学结果的结论。
我们进行了一项比较肾肿瘤单纯肿瘤剜除术与部分肾切除术的试验。我们评估的结果是存在阳性手术切缘的患者比例。我们的结果表明，对于该结果，单纯肿瘤剜除术并不劣于部分肾切除术。需要更长时间的随访来评估其他癌症控制结果。
