The primary aim of this study is to assess the feasibility of EM-navigation for percutaneous liver ablation.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the feasibility of our in-house developed navigation
system for percutaneous liver ablation. The study is considered feasible when
70% of the navigations are successful. A navigation is successful when the
ablation antenna is accurately visualized with respect to a registered 3D model
of the target lesion. An error between the determined position in the 3D model
and the actual position of the ablation needle as determined by a standard
verification CT scan of less than 10 mm is regarded accurate. 10 mm is regarded
as sufficient, as the total volume of the ablation zone is 3 cm or larger.
Secondary outcome
• To evaluate easiness of use and support for decisiveness during surgery using
stand-ardized System Usability Scale (SUS) questionnaires.
• To evaluate the time of all study-related actions during the surgery.
• To evaluate the accuracy of the registration from the pre-procedural CT to
the EM-field with the target registration error (distance tumor center CT -
tumor center EM).
• To evaluate the antenna tracking accuracy, which is defined as the distance
between the antenna in the US image and in the EM field.
Background summary
Accurately positioning an ablation antenna for percutaneous liver ablation
procedures can be challenging and time consuming. Image-guided navigation
surgery allows for optimal use and full integration of 3D models based on
patient-specific anatomy. Image-guided techniques have proven to be useful for
localization and visualization of lesions in liver surgery, and might be of use
for percutaneous liver ablation procedures. Commercially available navigation
systems have shown to be too complex or inaccurate, which we aim to improve
with this navigation system.
Study objective
The primary aim of this study is to assess the feasibility of EM-navigation for
percutaneous liver ablation.
Study design
A single-centre feasibility study.
Intervention
A semi-automatically segmented 3D model from the pre-procedural CT scan, is
registered with our EM-field. To achieve this, sensors are sticked to the
patient*s skin during the CT scan and will stay in place during the entire
procedure. By placing an EM-tracked, rigid cannula onto the ablation antenna we
can visualize the ablation antenna relative to the anatomy and the liver
lesions. Besides, EM-tracked ultrasound facilitates orientation during the
antenna placing procedure. The antenna is placed during breath hold to minimize
the influence of the breathing on the position of the liver.
Study burden and risks
Participation in the study will not involve additional visits to the hospital
for the included patients. Patients will be informed about the study during the
pre-operative outpatient clinic appointment. Informed consent will be obtained
during one of the patients visits to the hospital. Antenna placement takes
place with conventional decision making, by using ultrasound and CT. The
interventional radiologists are aware of the experimental setup, and are
therefore responsible for the navigation interpretation and actions. During the
procedure, the accuracy of the registration is assessed by checking the overlap
of CT based 3D model and the tracked ultrasound. The ultimate goal of this
project is to judge the potential use of the navigation setup for percutaneous
liver ablation procedures. A maximal delay of 20 minutes will be added to the
total time of the procedure, which is standardly 3 to 4 hours.
*
Plesmanlaan 121A
Amsterdam 1066CX
NL
Plesmanlaan 121A
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years;
- Patient or legal representative provides written informed consent form;
- Patient is scheduled for percutaneous liver ablation.
Exclusion criteria
- Ferro-magnetic implants in the abdominal or pelvic area that could influence
EM tracking;
- Pacemaker.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88039.041.24 |