Wendler Johann J, Pech Maciej, Fischbach Frank, Jürgens Julian, Friebe Björn, Baumunk Daniel, Porsch Markus, Blaschke Simon, Schindele Daniel, Siedentopf Sandra, Ricke Jens, Schostak Martin, Köllermann Jens, Liehr Uwe B
Department of Urology, Otto von Guericke University of Magdeburg, Germany.
Department of Radiology, Otto von Guericke University of Magdeburg, Germany.
Urology. 2018 Apr;114:224-232. doi: 10.1016/j.urology.2017.12.016. Epub 2018 Jan 2.
To assess the efficacy of irreversible electroporation (IRE) ablation of pT1a renal cell carcinoma (RCC) in the first prospective, monocentric phase 2a pilot ablate-and-resect study (Irreversible Electroporation of Kidney Tumors Before Partial Nephrectomy [IRENE] trial). It has been postulated that focal IRE can bring about complete ablation of soft-tissue tumors with protection of healthy peritumoral tissue and anatomic structures.
The first 7 study patients with biopsy-proven pT1a RCC (15-39 mm) underwent IRE. Percutaneous computed tomography-guided IRE was performed with electrocardiographic triggering under general anesthesia and deep muscle paralysis with 3-6 monopolar electrodes positioned within the renal tumor. Twenty-eight days later, the tumor region was completely resected to confirm tumor destruction pathologically. Individual results for these patients are displayed, described, and discussed.
Technical feasibility was attained in all patients, but electrode placement and ablation were complex, with a mean overall procedure time of 129 minutes. There were no major complications. Partial kidney resection was performed in 5 patients, and radical nephrectomy was performed in 2 patients because of central tumor location and ablation areas. Resections revealed by tumor, node, and metastasis classification of the International Union for Cancer Control 2017 no residual tumor as complete ablation in 4 cases (ypT0V0N0Pn0R0) and microscopic residual tumor cells as incomplete ablation in the other 3 cases (ypT1aV0N0Pn0R1).
Renal percutaneous IRE appears to be a safe treatment for pT1a RCC but requires substantial procedural effort. Resection specimens of the ablation zone revealed a high rate of microscopic incomplete ablation 4 weeks after IRE. According to these initial study results, curative, kidney-sparing ablation of T1a RCC appears possible but needs technical improvement to ensure complete ablation.
在首个前瞻性、单中心2a期先行消融再切除的试验（肾肿瘤部分肾切除术前不可逆电穿孔[IRENE]试验）中，评估不可逆电穿孔（IRE）消融pT1a期肾细胞癌（RCC）的疗效。据推测，局部IRE可实现软组织肿瘤的完全消融，同时保护健康的瘤周组织和解剖结构。
前7例经活检证实为pT1a期RCC（15 - 39毫米）的研究患者接受了IRE治疗。在全身麻醉和深度肌肉麻痹下，采用心电图触发，经皮计算机断层扫描引导下进行IRE，将3 - 6个单极电极置于肾肿瘤内。28天后，完整切除肿瘤区域，进行病理检查以确认肿瘤是否被破坏。展示、描述并讨论了这些患者的个体结果。
所有患者均实现了技术可行性，但电极放置和消融过程复杂，平均总手术时间为129分钟。未发生重大并发症。5例患者接受了部分肾切除术，2例患者因肿瘤位于中心及消融区域而接受了根治性肾切除术。根据国际癌症控制联盟2017年的肿瘤、淋巴结和转移分类，切除标本显示4例为完全消融无残留肿瘤（ypT0V0N0Pn0R0），另3例为不完全消融有镜下残留肿瘤细胞（ypT1aV0N0Pn0R1）。
经皮肾IRE似乎是治疗pT1a期RCC的一种安全方法，但需要大量的手术操作。IRE术后4周，消融区切除标本显示镜下不完全消融率较高。根据这些初步研究结果，T1a期RCC的根治性、保留肾单位的消融似乎是可行的，但需要技术改进以确保完全消融。
