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临床试验/NCT04187937
NCT04187937终止不适用

Feasibility of Ultrasound-based Navigation for Non-anatomical Liver Resections

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2020年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
R0 resection rate

研究概览

简要总结

In a non-anatomical resection of a liver tumor, only the part of the liver with the tumor and a safety margin of 5 - 10 mm are resected. This is done to ensure a negative resection margin, which means that no tumor cells are at the boundary of the resection. These non-anatomical resections can be performed repeatedly in case of recurrence. However, compared to anatomical resections, it is more challenging to keep a negative resection margin as anatomical landmarks cannot be used for intra-operative guidance.

In this study, the investigators aim to clinically evaluate a 3d navigation system, where navigated intra-operative ultrasound data is used to create a virtual model and a surgical plan.

详细描述

Surgical resection is the current gold standard for curative care of primary and metastatic hepatic tumors. This procedure involves the removal of the part of the liver where the tumor is located. This is typically achieved by removing the segments containing the tumor, so called anatomical resections. The downside of this technique is that it also removes a large part of healthy liver tissue. Recently, non-anatomical resections are becoming more popular, as they spare more healthy liver tissue than anatomical resections with similar oncological outcomes. In a non-anatomical resection, only the part of the liver with the tumor and a safety margin of 5 - 10 mm are resected. This is done to ensure a negative resection margin, which means that no tumor cells are at the boundary of the resection. These non-anatomical resections can be performed repeatedly in case of recurrence. However, compared to anatomical resections, it is more challenging to keep a negative resection margin as anatomical landmarks cannot be used for intra-operative guidance.

In the beginning of a non-anatomical resection, a resection line is drawn onto the liver surface to visualize where the resection shall be started. During the resection process, intra-operative ultrasound is used to confirm a safe distance to the tumor. Finally, once the depth is reached, the distance to the tumor is again confirmed on ultrasound and the tumor is removed. This is a challenging process which depends on the operator's ability and experience with mentally reconstructing the spatial relationships of the ultrasound image and the intra-operative scene. Additionally, the resection margin introduces artifacts and makes it harder to visualize the safety distance to the tumor on ultrasound.

To overcome these challenges, image-guidance systems have been introduced into the surgical workflow. These systems measure the pose of the surgical instruments and display their position on a virtual model of the anatomy. They mainly rely on a registration process to align a preoperative model with the patient's anatomy intraoperatively. This process is time-consuming, complex and error prone which is the main reason why such systems are rarely used.

In this study, the investigators aim to clinically evaluate a different approach, where navigated intra-operative ultrasound data is used to create a virtual model and a surgical plan on the spot. This does not require a separate registration process. With this approach a virtual draft of the surgical plan is created, which serves as a rough guidance map through the procedure. The investigators hypothesize that using such an intra-operative surgical draft allows the surgeon to acquire a negative resection margin.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Patients which are regularly scheduled for an open surgical liver resection
  • At least one tumor considered for non-anatomical resection
  • Lesion is visible on ultrasound imaging
  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Age >= 18 years

排除标准

  • Other clinically condition or disease that would (as deemed by the operating surgeon) significantly increase the risk of surgery
  • Lesion is close to major vessel (< 10 mm)
  • Lesion is too large to be visualized on ultrasound imaging
  • Emergency
  • Subjects not able to give informed consent (dementia)
  • Women of childbearing potential (less than 1 year post-menopausal)

结局指标

主要结局

R0 resection rate

时间窗: 30 days

Assessed by histopathological examination of the resected specimen. R0 is defined as a negative resection margin of \>1 mm.

次要结局

  • Correlation with tumor volume(pre-operative, expected to be up to 30 days)
  • Resection margin in mm(30 days)
  • Correlation with tumor size(pre-operative, expected to be up to 30 days)
  • Time for resection(intra-operative, expected to be up to 4 hours)
  • Number of re-resections(intra-operative, expected to be up to 4 hours)
  • Correlation with tumor location(pre-operative, expected to be up to 30 days)
  • Time for planning of the resection(intra-operative, expected to be up to 4 hours)
  • Correlation with tumor type(pre-operative, expected to be up to 30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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