Liver tumours
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Patient provides written informed consent form - Patient is scheduled for open liver resection and/or ablation or laparoscopic liver resection - 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main endpoint of the study is the accuracy of the navigation system during the surgical procedure. The accuracy of the navigation is calculated with the target registration error (TRE). The target registration error is calculated by measuring the distance between the center of the lesion in ultrasound, and the center of the lesion in the registered diagnostic scan. In group 2, an additional target registration error is calculated regarding the accuracy of the needle placement. This is done by comparing the distance between the needle tip and the center of the lesion in the 3D ultrasound sweep and the same distance in the navigation software. For both accuracy assessment a second ultrasound sweep is performed as gold standard. In addition, in patients in phase III, undergoing laparoscopic liver resection, the navigation is shown as an overlay onto the laparoscopic video image. Accuracy of this augmented reality is determined visually based on the distance between overlay and video of superficial anatomical landmarks, such as the liver contour, ligaments and superficial tumors. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Assess registration accuracy of vessel structures in the surroundings of the liver lesions. - Assess the time that is needed for registration and the total time added to surgery as efficiency measures. The time that is needed for positioning of the ablation needle is recorded as well. - Evaluate usability of the newly introduced technique for surgeons with questionnaires. | — |
Countries
Netherlands
Contacts
Public ContactKA Olthof
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed