Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Single Center Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- time to complete ablation
研究概览
简要总结
In primary and secondary liver tumors microwave ablation could be an alternative to surgical resection.It could be performed laparoscopically. Under ultrasound control the microwave device is placed in the tumor.Therefore spatial orientation is challenging: the tumor is often missed and the failure rate is high. During learning curve this could lead to incomplete tumor ablation and high rate of local recurrence. Targeting systems could optimize that. The CasOne-SPOT-system is an innovative electromagnetic tracking and navigation system for laparoscopic microwave ablation. In this study targeting precision using the SPOT-System should be compared to conventional laparoscopic ultrasound-guided microwave ablation. Therefore tumor mimics (1-2cm) will be created in ex-vivo pig livers and microwave ablation will be performed ultrasound guided or ultrasound navigated. The ablation procedures will be performed by two novices and two experienced surgeons. Aim of this trial is to is to evaluate, if laparoscopic microwave ablation could be facilitated by the use of the SPOT-navigation system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation
排除标准
- 未提供
结局指标
主要结局
time to complete ablation
时间窗: 0-10 minutes
time from beginning of the targeting process until to complete ablation of the tumor mimic
次要结局
- ablation completeness(up to 1 day)
研究者
Roger Wahba, MD, PhD
Principal Investigator
Universitätsklinikum Köln
