Multicentric Study Determining the Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 24
- 主要终点
- Comparison of the intra-operative modifications rates
研究概览
简要总结
The aim of this study is to assess the benefit of 3D models in the planning of hepatic resection by comparing the changes in the surgical plan based on the analysis of conventional preoperative images (CT-scan and MRI), compared to the surgical plan based on the analysis of 3D reconstruction.
详细描述
The detailed anatomical description of the liver described by Couinaud in 1954 is the basis for hepatic surgery. Surgical resection is the approach leading to the best survival rate in case of liver cancer. In hepatocarcinomas, systematic removal of the infected liver segment is considered the most effective technique to eliminate tumour, potential satellite nodules and avoid vascular spread. Resectability rate highly depends on the analysis of preoperative images. However, in 20% of cases, there are modifications compared with the initial surgical plan leading to an increase in morbidity rate.
In 2002, Couinaud highlighted the difficulty of identifying portal pedicles, especially because of anatomical variations, and recommended the use of a three-dimensional reconstruction from images provided by a helical scanner.
The hypothesis of the study is that 3D models would improve surgical planning leading to a decrease in intra-operative adjustments and mortality.
The aim of this multicentric, prospective study is to assess the benefit of 3D models in the surgical management of hepatocarcinomas, more specifically in the detailed analysis of 3D vascular structures and in the surgery planning with resection merges evaluation. The validation of this virtual method will be built on the comparison of the surgical plan based on the analysis of conventional preoperative images (CT-scan and MRI) and the surgical plan based on the analysis of 3D reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient with a hepatocarcinoma, eligible for surgical resection
- •Patient over 18 years old
- •Patient able to understand the study and provide written informed consent
- •Patient affiliated to the French social security system.
排除标准
- •Patient with other liver tumours
- •Patient whose general condition is not suitable for study participation (WHO ≥ 3)
- •Patient with a condition preventing its participation to study procedures, according to investigator's judgment
- •Patient with contraindications to injected CT-scan or MRI: allergic reaction to contrast agents, kidney failure, pacemaker, claustrophobia
- •Pregnancy or breastfeeding
- •Patient in exclusion period (determined by a previous study or in progress)
- •Patient in custody
- •Patient under guardianship.
结局指标
主要结局
Comparison of the intra-operative modifications rates
时间窗: At time of surgery
Modifications in the surgical planning compared to the plan based on the analysis of standard preoperative images (CT-scan and MRI) and the plan based on the 3D model analysis: changes in surgical resection type (by specifying the surgical act: tumorectomy, segmentectomy, bi-segmentectomy or lobectomy...) or no surgery.
次要结局
- Comparison of tumor(s) location(At time of surgery)
- Comparison of surgical merge size(At time of surgery)
- Mortality(At time of surgery and 3 months after surgery)
- Comparison of vascular network anatomy(At time of surgery)
- Comparison of resection merges(At time of surgery)
- Choice of surgical plan(At time of surgery)
- Modification of the initial surgical plan, if applicable(At time of surgery)
- Comparison of resection volumes(At time of surgery)
- Morbidity(At time of surgery and 3 months after surgery)
- Preoperative images independent analysis(3 years)