The aim of this study is to develop and evaluate a new ultrasound-based navigation system for guidance of resection and ablation of liver lesions during liver surgery. The feasibility and accuracy of this in-house developed navigation system is…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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.
Background summary
Image-guided navigation surgery allows the optimal use and full integration of
preoperative images during surgical procedures. Image-guided navigation systems
provide a perioperative link between the current location of the organ and
diagnostic images, and has the potential of reducing irradical resection and
ablations, as well as morbidity. In this study, ultrasound-based navigation is
investigated in liver surgery.
Study objective
The aim of this study is to develop and evaluate a new ultrasound-based
navigation system for guidance of resection and ablation of liver lesions
during liver surgery. The feasibility and accuracy of this in-house developed
navigation system is assessed during intraoperative use. A clinical workflow is
set up for use during open and laparoscopic surgery. The accuracy of
registration between intraoperative 3D ultrasound and preoperative images is
assessed by means of the target registration error of selected liver lesions.
In addition, augmented reality visualization of the navigation is tested for
laparoscopic liver procedures.
Study design
A single center observation feasibility study.
This study is designed as a single center observational feasibility study. The
duration of the study is 3 years. Patients are subject in this study until the
end of the surgical procedure. Patients eligible for inclusion are patients
admitted to the Netherlands Cancer Institute - Antoni van Leeuwenhoek, planned
to undergo 1) resection of liver lesions in open surgery and/or 2) ablation of
one or more liver lesions during open liver surgery. The targeted lesions can
be from any origin.
The navigation system is introduced in 28 patients during phase I of the study.
Here, the intraoperative situation is registered manually to the preoperative
diagnostic scan. Additionally, in these patients we collect data to develop an
automatic registration algorithm.
In phase II, the developed algorithm for automatic registration is used.
Firstly, feasibility of this algorithm is tested in an initial group of 5 to 8
patients during surgical resections in open liver surgery. An interim analysis
decides whether we proceed with this automatic registration algorithm or if
adjustments in the setup are necessary. From now on, phase II is divided in
group 1 of 28 patients scheduled for open resection, and group 2 of 28 patients
for ablation during open resection.
In phase III, the navigation system will be tested during laparoscopic liver
procedures. Similar to phase I of this study, the intraoperative situation is
registered manually to the preoperative diagnostic scan. In addition, the
navigation will be shown to the surgeon by an augmented reality over the
laparoscopic video image. The minimal invasive workflow will be first optimized
in 5 patients as a learning curve is expected, after which 28 patients will be
included.
Study burden and risks
The nature of this study does not cause expectations of any adverse events to
occur that are related to the intervention. The electromagnetic tracking system
has been used in multiple studies in our institute without any adverse events.
The sensor on the liver surface has been used in our institute in over 40
patients of a previous liver navigation study and has not caused any adverse
events. Measurements shall only be performed during the scheduled operation
under full anaesthesia and physical monitoring. The added time will maximally
be 15 minutes, which is added in the total anaesthesia time of a surgical
procedure that normally lasts 3 or 4 hours.
The planned surgical procedure will not be influenced by the measurements and
the planned radiofrequency/microwave ablation during the surgical procedure
will not be influenced by the measurements. Hence, patient treatment will not
be influenced by the measurements.
Subjects who participate in the test will not benefit from the test, nor
unacceptable additional discomfort will be experienced.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
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
- 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
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL65724.031.18 |
| OMON | NL-OMON29374 |