Clinical trial NCT04187937: Feasibility of Ultrasound-based Navigation for Non-anatomical Liver Resections
Official title: Feasibility of Ultrasound-based Navigation for Non-anatomical Liver Resections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Neoplasm
Keywords: Image-Guidance
Liver Neoplasm
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2019-12-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized, non-controlled, single-arm feasibility study of intraoperative ultrasound-based navigation for non-anatomical liver resections
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: R0 resection rate
timeFrame: 30 days
Secondary outcomes:
measure: Number of re-resections
timeFrame: intra-operative, expected to be up to 4 hours
measure: Resection margin in mm
timeFrame: 30 days
measure: Correlation with tumor size
timeFrame: pre-operative, expected to be up to 30 days
measure: Correlation with tumor volume
timeFrame: pre-operative, expected to be up to 30 days
measure: Correlation with tumor type
timeFrame: pre-operative, expected to be up to 30 days
measure: Correlation with tumor location
timeFrame: pre-operative, expected to be up to 30 days
measure: Time for planning of the resection
timeFrame: intra-operative, expected to be up to 4 hours
measure: Time for resection
timeFrame: intra-operative, expected to be up to 4 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern
Study officials:
affiliation: Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
name: Anja Lachenmayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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