Department of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Department of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Urol Oncol. 2019 Mar;37(3):183.e1-183.e8. doi: 10.1016/j.urolonc.2018.11.008. Epub 2018 Nov 30.
Irreversible electroporation (IRE) has the potential to overcome limitations of thermal ablation, enabling small renal mass (SRM) ablation near vital structures.
To assess feasibility and safety of percutaneous IRE for the treatment of SRMs.
This prospective study is a phase 2 trial (NCT02828709) of IRE for patients with SRMs. Primary endpoints are feasibility and safety. Device- and procedural-adverse events were assessed by Clavien-Dindo and Common Terminology Criteria for Adverse Events version 4.0 grading systems. Technical feasibility was assessed by recording the technical success of the procedures. Technical success was evaluated by performing a CT immediately after ablation where complete tumor coverage and nonenhancement were evaluated. Tumor charcateristics and patient characteristics, procedural and anesthesia details, postprocedural events, and perioperative complications were recorded.
Ten SRMs were included with a mean tumor size of 2.2 cm (range 1.1-3.9 cm) were treated with IRE. Renal mass biopsies revealed 7 clear cell and 1 papillary renal cell carcinoma. Two renal mass biopsies were nondiagnostic. The median follow-up was 6 months (range 3-12 months). Technical success was achieved in 9 out of 10 cases. One patient had a grade 3 Clavien-Dindo complication (1/10, 95% Confidence interval (CI) 0.0179-0.4041). Mean anesthesia time was 3.7 hours (range 3-5 hours), mean procedural time was 2.1 hours (range 1 hour 45 minutes-2 hours 30 minutes) and mean ablation time was 50 minutes (range 20 minutes-1 hour 45 minutes). The creatinine preoperative and postoperative (1 week, 3 months, 6 months, and 12 months) did not significantly differ. In total, 8 out of 10 cases did not experience postoperative pain.
IRE in SRMs is safe and feasible. Renal function is not affected by IRE and postoperative pain is rare. Anesthesia time and procedural time are a potential concern.
不可逆电穿孔（IRE）有可能克服热消融的局限性，使靠近重要结构的小肾肿瘤（SRM）能够进行消融。
评估经皮 IRE 治疗 SRM 的可行性和安全性。
这是一项针对 SRM 患者的 IRE 前瞻性 2 期试验（NCT02828709）。主要终点是可行性和安全性。采用 Clavien-Dindo 和通用不良事件术语标准 4.0 分级系统评估设备和程序不良事件。通过记录消融后立即进行的 CT 评估来评估技术可行性，评估内容包括完全肿瘤覆盖和无增强。记录肿瘤特征和患者特征、程序和麻醉细节、术后事件以及围手术期并发症。
10 个 SRM 肿瘤纳入研究，平均肿瘤大小为 2.2cm（范围 1.1-3.9cm），均接受 IRE 治疗。肾肿瘤活检显示 7 例为透明细胞癌，1 例为乳头状肾细胞癌。2 例肾肿瘤活检无法诊断。中位随访时间为 6 个月（范围 3-12 个月）。10 例中有 9 例达到技术成功。1 例患者发生 3 级 Clavien-Dindo 并发症（1/10，95%置信区间[CI]0.0179-0.4041）。平均麻醉时间为 3.7 小时（范围 3-5 小时），平均手术时间为 2.1 小时（范围 1 小时 45 分钟-2 小时 30 分钟），平均消融时间为 50 分钟（范围 20 分钟-1 小时 45 分钟）。术前和术后（1 周、3 个月、6 个月和 12 个月）的血肌酐无显著差异。总共有 8 例患者术后没有疼痛。
IRE 治疗 SRM 是安全可行的。IRE 不会影响肾功能，术后疼痛罕见。麻醉时间和手术时间是一个潜在的问题。
