Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver: A Prospective, Non Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- TRE, measuring the error in the prediction of a surgical target location when using the navigation system.
研究概览
简要总结
Preoperative image-guided data correlates with the actual intraoperative reality. Computer-assisted preoperative planning combined with intraoperative mapping of even very small lesions allows for improved accuracy during complete oncological resection / ablation. In the short- and long-term this possibly results in better patient outcome.
详细描述
Background
The aim of this study is to analyze the available accuracy of a computer-assisted approach to liver surgery and microwave ablation. The term 'computer-assisted' refers to 1) using 3D models of patient anatomy for extended orientation during the planning of the intervention and 2) using an image guidance system (similar to a GPS in a car) that allows for precise targeting of desired anatomical structures (e.g. intrahepatic tumor, bile ducts / vasculature) in the setting of successfully treating liver malignancies. Furthermore, we would like to demonstrate, that image guided open liver surgery is technically feasible, whenever the correlation between preoperative image-guided data and the intraoperative setting can be achieved with a known accuracy.
Eventually, this technology, like in other surgical domains, will lead to successively implemented technical guiding functionalities that could potentially improve patient outcome.
Objective
To date, first systems (CE marked medical devices) are available that have been specifically developed for image-guided open liver surgery. The systems tracks positions of surgical instruments in or near the target organs and visualizes the instruments position in correlation to patients medical image data (i.e. 3D-CT) on the computer screen. Surgeons benefit from a view to a virtual scene (on a computer screen) in which CT images, together with models of the vascular structures, tumors and organ boundaries, are intuitively visible. The surgeon can see the moving instrument, just like the movement of a car can be seen in a GPS system
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •1.Written informed consent
- •2.Male patients and non-pregnant, non-lactating females aged ≥18 years of age (negative serum/urine pregnancy test result at screening)
- •3.Patients must be candidates for surgical liver resection and/or MWA (at least one anatomical segment) of primary or metastatic liver cancer. The liver tumors must be present on preoperative imaging study (CT and/or MRI).
- •Exclusion Criteria
- •1.Any condition which, in the judgment of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
- •2.A mental condition rendering the patient unable to provide informed consent.
- •3.Patients with hereditary hematological / coagulation disorders unrelated to their liver disease or cirrhosis of the liver classified as Child's B or C.
排除标准
- 未提供
结局指标
主要结局
TRE, measuring the error in the prediction of a surgical target location when using the navigation system.
时间窗: 12 months
次要结局
- 1.Identification of suitable landmarks for registration(15 months)