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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04187937
Enrollment
1
Registered
2019-12-05
Start date
2020-06-17
Completion date
2022-02-16
Last updated
2022-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Neoplasm

Keywords

Image-Guidance, Liver Neoplasm

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.

Interventions

DEVICEStereotactic image-guided resection

Stereotactic image-guided resection with an ultrasound-based image-guidance system.

Sponsors

University of Bern
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Non-randomized, non-controlled, single-arm feasibility study of intraoperative ultrasound-based navigation for non-anatomical liver resections

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
R0 resection rate30 daysAssessed by histopathological examination of the resected specimen. R0 is defined as a negative resection margin of \>1 mm.

Secondary

MeasureTime frame
Resection margin in mm30 days
Correlation with tumor sizepre-operative, expected to be up to 30 days
Correlation with tumor volumepre-operative, expected to be up to 30 days
Number of re-resectionsintra-operative, expected to be up to 4 hours
Correlation with tumor locationpre-operative, expected to be up to 30 days
Time for planning of the resectionintra-operative, expected to be up to 4 hours
Time for resectionintra-operative, expected to be up to 4 hours
Correlation with tumor typepre-operative, expected to be up to 30 days

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026