Buijs Mara, van Lienden Krijn P, Wagstaff Peter Gk, Scheltema Matthijs Jv, de Bruin Daniel M, Zondervan Patricia J, van Delden Otto M, van Leeuwen Ton G, de la Rosette Jean Jmch, Laguna M Pilar
Academic Medical Center, Department of Urology, University of Amsterdam, Amsterdam, Netherlands.
Academic Medical Center, Department of Radiology, University of Amsterdam, Amsterdam, Netherlands.
JMIR Res Protoc. 2017 Feb 16;6(2):e21. doi: 10.2196/resprot.6725.
Irreversible electroporation (IRE) is an emerging technique delivering electrical pulses to ablate tissue, with the theoretical advantage to overcome the main shortcomings of conventional thermal ablation. Recent short-term research showed that IRE for the ablation of renal masses is a safe and feasible treatment option. In an ablate and resect design, histopathological analysis 4 weeks after radical nephrectomy demonstrated that IRE-targeted renal tumors were completely covered by ablation zone. In order to develop a validated long-term IRE follow-up study, it is essential to obtain clinical confirmation of the efficacy of this novel technology. Additionally, follow-up after IRE ablation obliges verification of a suitable imaging modality.
The objectives of this study are the clinical efficacy and safety of IRE ablation of renal masses and to evaluate the use of cross-sectional imaging modalities in the follow-up after IRE in renal tumors. This study conforms to the recommendations of the IDEAL Collaboration and can be categorized as a phase 2B exploration trial.
In this prospective clinical trial, IRE will be performed in 20 patients aged 18 years and older presenting with a solid enhancing small renal mass (SRM) (≤4 cm) who are candidates for ablation. Magnetic resonance imaging (MRI) and contrast-enhanced ultrasound (CEUS) will be performed at 1 day pre-IRE, and 1 week post-IRE. Computed tomography (CT), CEUS, and MRI will be performed at 3 months, 6 months, and 12 months post-IRE.
Presently, recruitment of patients has started and the first inclusions are completed. Preliminary results and outcomes are expected in 2018.
To establish the position of IRE ablation for treating renal tumors, a structured stepwise assessment in clinical practice is required. This study will offer fundamental knowledge on the clinical efficacy of IRE ablation for SRMs, potentially positioning IRE as ablative modality for renal tumors and accrediting future research with long-term follow-up.
Clinicaltrials.gov registration number NCT02828709; https://clinicaltrials.gov/ct2/show/NCT02828709 (archived by WebCite at http://www.webcitation.org/6nmWK7Uu9). Dutch Central Committee on Research Involving Human Subjects NL56935.018.16.
不可逆电穿孔（IRE）是一种新兴的通过输送电脉冲来消融组织的技术，理论上具有克服传统热消融主要缺点的优势。近期的短期研究表明，IRE用于肾肿块消融是一种安全可行的治疗选择。在一项先消融后切除的设计中，根治性肾切除术后4周的组织病理学分析显示，IRE靶向的肾肿瘤完全被消融区覆盖。为开展一项经过验证的IRE长期随访研究，获得这项新技术疗效的临床确认至关重要。此外，IRE消融后的随访需要验证合适的成像方式。
本研究的目的是评估IRE消融肾肿块的临床疗效和安全性，并评价横断面成像方式在肾肿瘤IRE术后随访中的应用。本研究符合IDEAL协作组的建议，可归类为2B期探索性试验。
在这项前瞻性临床试验中，将对20例年龄在18岁及以上、患有实性强化小肾肿块（SRM）（≤4 cm）且适合消融的患者进行IRE治疗。在IRE前1天和IRE后1周进行磁共振成像（MRI）和对比增强超声（CEUS）检查。在IRE后3个月、6个月和12个月进行计算机断层扫描（CT）、CEUS和MRI检查。
目前，患者招募已开始，首批纳入工作已完成。预计2018年得出初步结果和结局。
为确立IRE消融治疗肾肿瘤的地位，临床实践中需要进行结构化的逐步评估。本研究将提供关于IRE消融SRM临床疗效的基础知识，可能将IRE定位为肾肿瘤的消融方式，并为未来的长期随访研究提供依据。
Clinicaltrials.gov注册号NCT02828709；https://clinicaltrials.gov/ct2/show/NCT02828709（由WebCite存档于http://www.webcitation.org/6nmWK7Uu9）。荷兰人类受试者研究中央委员会NL56935.018.16。
