Retrospective and Perspective Analysis of Short, Medium and Long Term Clinical Performance of Patients Undergoing MicrowaveThermal Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Time to Local Progression
研究概览
简要总结
The goal of this observational study is to collect data on efficacy and safety of microwave ablation (MWA) used to treat subjects with primary and secondary liver malignancies and renal malignancies. The main question it aims to evaluate the short, medium and long-term clinical course of patients treated with MWA.
Participants will not alter their normal clinical and therapeutic practice, due to the observational nature of the study, and all data regarding microwave treatments will be collected (including demographic data). follow their normal clinical and therapeutic path
详细描述
Observational, retrospective and prospective, monocentric study. The objective is to evaluate the short, medium and long-term clinical course of patients undergoing microwave ablation (MWA) for small renal tumors and primary and secondary liver neoplasms. Evaluation of clinical efficacy (progression free survival),safety and technical outcome of microwave ablation as well as clinical outcome of the procedure will be evaluated.At the end of the follow-up periods, the data collected will be compared with those available in the literature on MWA, cryoablation (CA), radiofrequency ablation (RFA) and surgical resection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •> 18 years with primary or secondary liver tumors or small kidney tumors that are not candidates for surgery or cannot be radically resected by surgery alone
- •Primary liver cancer: up to three liver nodules ≤ 3 cm
- •Secondary hepatic tumours: up to nodules ≤ 3 cm provided that the objective is complete hepatic clearance Renal tumours: single or multiple (von Hippel Lindau syndrome), < 4 cm
排除标准
- •pregnant women
- •non-manageable coagulopathies
- •Extended extrahepatic or extrarenal disease
- •for liver ablation: presence of bilio-digestive anastomosis
结局指标
主要结局
Time to Local Progression
时间窗: From date of ablation until death from any cause; evaluated up to 5 years
Time from ablation to imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)
Local Tumor Progression Free Survival
时间窗: From date of ablation until death from any cause; evaluated up to 5 years
Based on imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)
次要结局
- Overall Survival (OS)(From date of ablation until death from any cause; evaluated up to 5 years)
- Organ specific Progression Free Survival (PFS)(From date of ablation until death from any cause; evaluated up to 5 years)
- Progression Free Survival (PFS)(From date of ablation until death from any cause; evaluated up to 5 years)
研究者
Francesco De Cobelli
Professor of Radiology, Clinical and Experimental Radiology
IRCCS San Raffaele