The Safety and Feasibility of Irreversible Electroporation for the Ablation of Small Renal Masses
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- safety IRE ablation procedure (evaluating device and procedural adverse events using CTCAE v4.0)
研究概览
简要总结
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 tumours.
This is a prospective, human, in-vivo study among 20 patients presenting with solid enhancing SRM on cross sectional imaging suspect for renal cell carcinoma (RCC). Preoperatively, imaging is required through Magnetic Resonance Imaging (MRI), Contrast-enhanced ultrasound (CEUS) and contrast-enhanced Computed Tomography (CT). Furthermore, serum creatinine levels and VAS scores are obtained. A biopsy of the SRM will be performed in preoperative setting. IRE ablation will be performed using CT-guidance and ablation success will be measured directly after the ablation through contrast-enhanced CT. Device related adverse events (AE) will be registered using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 guideline. One week post ablation only CEUS and MRI will be performed to limit exposure to ionizing radiation. At 3 months, 6 months and 12 months post ablation CEUS, MRI and CT will be performed. Additionally, at these time points serum creatinine levels and VAS scores will be obtained, and quality of life will be assessed through SF-36 questionnaires. Residual and recurrent disease will be assessed through tissue enhancement on cross sectional imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Solid, enhancing mass on cross sectional imaging
- •Signed informed consent
- •Candidate for focal ablative therapy
排除标准
- •Irreversible bleeding disorders
- •Inability/unwillingness to interrupt anticoagulation therapy
- •Previous cryoablation, RFA or partial nephrectomy in affected kidney
- •Anaesthesia Surgical Assignment (ASA), category ≤ IV
- •ICD / pacemaker
结局指标
主要结局
safety IRE ablation procedure (evaluating device and procedural adverse events using CTCAE v4.0)
时间窗: 2 years
To determine the safety and feasibility of IRE ablation of small renal masses (≤ 4cm), by evaluating device and procedural adverse events using CTCAE v4.0
次要结局
- Clinical efficacy ((non-)presence of tumour enhancement on cross-sectional imaging post IRE)(2 years)
- Cross sectional imaging post ablation(2 years)
- Renal function(2 years)
- Average length of hospital stay(2 years)
- Quality of Life(2 years)
- Postoperative pain score(1 year)
研究者
Dr. Prof. M.P. Laguna Pes
Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)