Urology Clinical Unit, University Hospital of Jerez de La Frontera, Ctra. Trebujena, S/N, 11407, Jerez de La Frontera, Cádiz, Spain.
Department of Urology and Nephrology, Virgen del Rocío University Hospital, Biomedical Institute of Seville (Ibis), CSIC/University of Seville, Seville, Spain.
Eur Radiol. 2023 Nov;33(11):7371-7379. doi: 10.1007/s00330-023-09779-7. Epub 2023 Jun 6.
The standard therapy for small renal masses (SRMs) remains partial nephrectomy (PN), which is associated with relatively high morbidity and complication rate. Therefore, percutaneous radiofrequency ablation (PRFA) emerges as an alternative therapy. This study aimed to compare the efficacy, safety, and oncological outcomes of PRFA versus PN.
A multicenter non-inferiority study with retrospective analysis of 291 patients with SRMs (N0M0), who underwent PN or PRFA (2:1), recruited prospectively from two hospitals in the Andalusian Public Health System, Spain, between 2014 and 2021. Comparisons of treatment features were evaluated using the t test, Wilcoxon-Mann-Whitney U test, chi-square test, Fisher test, and Cochran-Armitage trend test. Kaplan-Meier curves depicted overall survival (OS), local recurrence-free survival (LRFS), and metastasis-free survival (MFS) rates in the overall study population.
A total of 291 consecutive patients were identified; 111 and 180 patients underwent PRFA and PN, respectively. Median follow-up time was 38 and 48 months, and mean hospitalization days were 1.04 and 3.57 days, respectively. The variables underpinned with high surgical risk were significantly increased in PRFA compared to those in PN (mean age was 64.56 and 57.47 years, the solitary kidney presence was 12.6% and 5.6%, ASA score ≥ 3 was 36% and 14.5%, respectively). The rest of oncological outcomes were comparable amongst PRFA and PN. Patients undergoing PRFA did not improve OS, LRFS, and MFS compared to those undergoing PN. Limitations comprise retrospective design and limited statistical power.
PRFA for SMRs in high-risk patients is non-inferior in terms of oncological outcomes and safety compared to PN.
Our study has a direct clinical application as it proves that radiofrequency ablation is an effective and uncomplicated therapeutic option for patients with small renal masses.
•There are non-inferiority results in overall survival, local recurrence-free survival, and metastasis-free survival between PRFA and PN. •Our two-center study showed that PRFA is non-inferior to PN in oncological outcomes. •Contrast-enhanced power ultrasound-guided PRFA provides an effective therapy for T1 renal tumors.
小肾肿瘤(SRM)的标准治疗仍然是部分肾切除术(PN),但这种治疗方法与相对较高的发病率和并发症发生率有关。因此,经皮射频消融术(PRFA)作为一种替代疗法出现了。本研究旨在比较 PRFA 与 PN 的疗效、安全性和肿瘤学结果。
这是一项多中心非劣效性研究,对 2014 年至 2021 年期间在西班牙安达卢西亚公共卫生系统的两家医院前瞻性招募的 291 名接受 PN 或 PRFA(2:1)治疗的 SRM(N0M0)患者进行回顾性分析。采用 t 检验、Wilcoxon-Mann-Whitney U 检验、卡方检验、Fisher 检验和 Cochran-Armitage 趋势检验比较治疗特征。Kaplan-Meier 曲线描绘了总体研究人群的总生存(OS)、局部无复发生存(LRFS)和无转移生存(MFS)率。
共确定了 291 例连续患者;111 例和 180 例患者分别接受了 PRFA 和 PN 治疗。中位随访时间分别为 38 个月和 48 个月,平均住院天数分别为 1.04 天和 3.57 天。PRFA 组与 PN 组相比,具有较高手术风险的变量显著增加(平均年龄分别为 64.56 岁和 57.47 岁,单肾存在率分别为 12.6%和 5.6%,ASA 评分≥3 分别为 36%和 14.5%)。PRFA 和 PN 之间的其他肿瘤学结果相当。与接受 PN 的患者相比,接受 PRFA 的患者在 OS、LRFS 和 MFS 方面没有改善。局限性包括回顾性设计和有限的统计能力。
对于高危患者的 SMRs,PRFA 在肿瘤学结果和安全性方面与 PN 相比是非劣效的。
我们的研究具有直接的临床应用价值,因为它证明了射频消融术是一种有效且简单的治疗小肾肿瘤的方法。
PRFA 在总体生存、局部无复发生存和无转移生存方面与 PN 相比具有非劣效性。
我们的两中心研究表明,PRFA 在肿瘤学结果方面与 PN 非劣效。
增强超声引导下的 PRFA 为 T1 期肾肿瘤提供了一种有效的治疗方法。