Variability of Microwave Ablation Volume Based on Clinical, Radiological, Biological, and Tissue Factors : a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Small final ablation axis measured on the post-procedure imaging modality considered to be the most reliable.
研究概览
简要总结
Microwave ablation is a minimally invasive technique whose planning relies on manufacturer tables derived from ex vivo models that do not account for patient or tumor-specific factors. In clinical practice, the actual ablation volume often differs from the planned volume due to liver characteristics, vascular proximity, and tumor biology.
This study aims to assess the variability between ablation small axis during percutaneous microwave ablation of liver lesions. The influence of patient-related (fibrosis, steatosis, portal flow) and tumor-related factors (location, histology, prior treatment) will be evaluated. Small axis and volume will be compared with volumes measured on immediate post-procedural CT and on CT/MRI at 6-12 weeks, accounting for expected tissue shrinkage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Treated with percutaneous hepatic microwave ablation under CT or ultrasound guidance
- •Adult treated for one or more liver lesions
- •Patients with available follow-up imaging
排除标准
- •Two treatment cycles on the same lesion during the same session.
- •Reoperation on the same lesion.
- •Planned volume not available (no manufacturer data, not specified in the surgical report).
- •No control imaging injected between 1 and 4 months post-procedure.
- •Final ablation volume not measurable (e.g., artifacts, no injection on MRI).
- •No definitive diagnosis of the nature of the tumor on imaging and no histology available.
结局指标
主要结局
Small final ablation axis measured on the post-procedure imaging modality considered to be the most reliable.
时间窗: 12 weeks
The final short axis will preferably be measured (in mm) on MRI at 6-12 weeks. If inter-patient variability in volume shrinkage exceeds 5%, the modality with the lowest relative variability (usually the immediate CT scan) will be used as the reference for estimating the final volume.
次要结局
未报告次要终点
研究者
Valérie LAURENT
MD-PhD
Central Hospital, Nancy, France