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临床试验/NCT05495529
NCT05495529已完成不适用

Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors With High Iatrogenic Risk

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2013年1月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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