Is 3D Modeling From Non-contrast CT Accurate for Minimally Invasive Lung Segmentectomies ?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- RELIABILITY of 3D-CT and 2D-CT reconstructions regarding bronchovascular anatomy and tumor location - composite 1
研究概览
简要总结
To assess the RELIABILITY in terms of accuracy of 3D-CT and 2D-CT reconstructions compared to intraoperative data regarding bronchovascular anatomy and tumor location. 3D CT reconstruction (CT scan without contrast injection) with Innersight3D® is equivalent to 2D CT (CT scan with contrast injection) for planning a minimally invasive lung segmentectomy.
Evaluate the impact of 3D reconstruction (from a CT scan without injection of contrast agent) on intraoperative and postoperative results
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patient ≥ 18 years
- •Patient agreeing to participate in the study
- •Patient with clinical stage IA lung lesions ≤ 2 cm in diameter AND a suspected or proven malignancy.
- •Chest CT scan available without and then with contrast
- •Eligible for VATS or RATS segmentectomy based on respiratory explorations
排除标准
- •Patient refusal to participate in the study
- •Allergic reactions to radiographic contrast agents
- •History of ipsilateral cardiothoracic surgery
- •Open segmentectomy (thoracotomy)
- •Histology different from that of NSCLC
- •Inability to provide the subject with informed information (difficulty understanding the subject, insufficient command of French, etc.)
- •Pregnant or breastfeeding women
- •Severe cognitive impairment and/or suspicion of lack of compliance or adherence, in the investigator's judgment
结局指标
主要结局
RELIABILITY of 3D-CT and 2D-CT reconstructions regarding bronchovascular anatomy and tumor location - composite 1
时间窗: Immediately after surgery
Accuracy between predicted bronchovascular anatomy by 3D CT and 2D CT reconstruction compared to intraoperative observations
RELIABILITY of 3D-CT and 2D-CT reconstructions regarding bronchovascular anatomy and tumor location - composite 2
时间窗: Immediately after surgery
Accuracy between predicted tumor location by 3D CT and 2D CT reconstruction compared to intraoperative observations
次要结局
未报告次要终点