liver cancer
Conditions
Interventions
The patient is operated on a surgical bed with a field generator positioned
under the bed or near the head of the patient. The surgical procedure will
start according to the standard practice. After
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Patient provides written informed consent form - Patient is scheduled for liver resection
Exclusion criteria
Exclusion criteria: - Ferro-magnetic implants in the abdominal or thoracic area that could influence electromagnetic tracking or the electromagnetic field - Pacemaker - Non-visible lesions on intraoperative ultrasound imaging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the feasibility of ultrasound-based navigation for assistance during hepatic resection. The navigational workflow is deemed feasible when 70% of the navigations are successful. A navigation is successful when instruments can be accurately shown with respect to the 3D model of the resection plane. This is measured by comparing the distance between the navigated pointer at the resection plane (shown by the navigation system) and that same distance measured by postoperative imaging of the resected specimen. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The easiness of use during surgery using standardized System Usability Scale (SUS) questionnaires amongst the surgeons, together with a questionnaire regarding expected effects on clinical outcome. 2. The time of all study-related actions during the surgery, such as tumour delineation and verification. 3. The difference between the planned resection margin and actual resection margin. | — |
Countries
Netherlands
Outcome results
None listed