Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors With High Iatrogenic Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Feasability
研究概览
简要总结
This study aims to analyse retrospectively the feasibility, the safety, and the efficiency, of biliary or digestive protection with room air interposition for thermal ablation of central liver tumors with high iatrogenic risk.
Thermal ablation is a mini-invasive and curative treatement of liver tumors. However, it requires to be carefull about surrunding organs, such as digestive structures or central biliary tree, which can be injured if not insulated.
The technique of gas interposition to protect adjacent gut is already known and validated with carbonic gas. Nevertheless, resorption of this gas is very fast, making its use tricky to keep a correct insulation during the whole thermal ablation process.
Room air interposition is easy to use and can offer a slow resorption speed. Furthermore no datas are available concerning the use of room air whatever the organ protected, and the protection of central biliary tree whatever the gas used.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feasability
时间窗: 1 day
Technical succes of the procedure = feasibility of insulation with room air
Efficacity
时间窗: 2 months
Response in imaging (MRI or CT) for the tumor treated with thermal ablation
Clinical success
时间窗: 2 months
Overall survival
Security
时间窗: 2 months
Complications (intraoperative clinical or radiological event/abnormality, biological perturbation, clinical event in hospitalization report, imaging request), classified according to SIR (Society of Interventional Radiology) classification in two classes: minor (no additional therapy needed) and major (specific therapy needed) complications.
次要结局
- Local tumorous recurrence free survival(2 months)
- Progression free survival(2 months)
- Local and distant recurrence(2 months)
