ltrasound-based navigation during liver surgery
Recruiting
- Conditions
- iver lesions from any origin
- Registration Number
- NL-OMON29374
- Lead Sponsor
- The Netherlands Cancer Institute –Antoni van Leeuwenhoek Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 92
Inclusion Criteria
Age = 18 years
- Patient provides written informed consent form
- Patient is scheduled for open liver resection and/or ablation
- Presence of at least one centrally located liver lesion
- Contrast-enhanced MRI or CT scan not older than 2 months
- Lesion diameter under 8 cm
- Lesion located within 5 cm of the liver surface
Exclusion Criteria
Metal implants in the abdominal or thoracic area that could influence electromagnetic tracking or other influences
that would influence the electromagnetic field
- Isoechoic liver lesions or lesions with a complete radiological response
- Pregnancy
- Pacemaker
- Presence of large cysts (> 5 cm in diameter) near the target liver lesion
- Diagnostic scan older than 2 months at time of surgery
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accuracy of the navigation system, calculated with the target registration error. In group 2, additional target registration error is calculated for the needle placement.
- Secondary Outcome Measures
Name Time Method - Assess registration accuracy of vessel structures in the surroundings of the liver lesions.<br>- Second, the time that is needed for registration and the total time added to surgery are assessed as efficiency measures. The time that is needed for positioning of the ablation needle is recorded as well.<br>- Assess the time for registration and the total time added to surgery, time for needle positioning and total added time to surgery as efficiency measures.<br>- Evaluate usability of the newly introduced technique for surgeons with questionnaires