ltrasound-based navigation during liver resectio
- Conditions
- liver cancer1001981510019818
- Registration Number
- NL-OMON51512
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
- Age >= 18 years
- Patient provides written informed consent form
- Patient is scheduled for liver resection
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoint is the feasibility of ultrasound-based navigation for<br /><br>assistance during hepatic resection. The navigational workflow is deemed<br /><br>feasible when 70% of the navigations are successful. A navigation is successful<br /><br>when instruments can be accurately shown with respect to the 3D model of the<br /><br>resection plane. This is measured by comparing the distance between the<br /><br>navigated pointer at the resection plane (shown by the navigation system) and<br /><br>that same distance measured by postoperative imaging of the resected specimen. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. The easiness of use during surgery using standardized System Usability Scale<br /><br>(SUS) questionnaires amongst the surgeons, together with a questionnaire<br /><br>regarding expected effects on clinical outcome.<br /><br>2. The time of all study-related actions during the surgery, such as tumour<br /><br>delineation and verification.<br /><br>3. The difference between the planned resection margin and actual resection<br /><br>margin.</p><br>