Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver (CALS)
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver: A Prospective, Non Randomized Study|
- TRE, measuring the error in the prediction of a surgical target location when using the navigation system. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- 1.Identification of suitable landmarks for registration [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Other: Abdominal surgery
The aim of this study is to analyze the available accuracy of a computer-assisted approach to liver surgery and microwave ablation. The term 'computer-assisted' refers to 1) using 3D models of patient anatomy for extended orientation during the planning of the intervention and 2) using an image guidance system (similar to a GPS in a car) that allows for precise targeting of desired anatomical structures (e.g. intrahepatic tumor, bile ducts / vasculature) in the setting of successfully treating liver malignancies. Furthermore, we would like to demonstrate, that image guided open liver surgery is technically feasible, whenever the correlation between preoperative image-guided data and the intraoperative setting can be achieved with a known accuracy.
Eventually, this technology, like in other surgical domains, will lead to successively implemented technical guiding functionalities that could potentially improve patient outcome.
To date, first systems (CE marked medical devices) are available that have been specifically developed for image-guided open liver surgery. The systems tracks positions of surgical instruments in or near the target organs and visualizes the instruments position in correlation to patients medical image data (i.e. 3D-CT) on the computer screen. Surgeons benefit from a view to a virtual scene (on a computer screen) in which CT images, together with models of the vascular structures, tumors and organ boundaries, are intuitively visible. The surgeon can see the moving instrument, just like the movement of a car can be seen in a GPS system
In patients requiring extensive surgery (eg. extended right hemihepatectomy), accurate calculations of the remaining liver volume are essential to avoid postoperative liver failure with potentially serious postoperative complications or even death, resulting from an inadequate remaining liver volume (ie "small-for-size syndrome"). In high-risk liver resections, use of computer programs, such as MeVis (MeVis Medical Solutions Inc.), provide the surgeon with accurate preoperative information, allowing him / her to judge the feasibility of the planned surgical resection based on preoperative liver volume analysis and evaluation of the planned resection line in relation to essential structures (ie. major vessels / bile ducts).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474694
|Dep. of visceral and Transplant Surgery, Bern University Hospital|
|Berne, Switzerland, 3010|
|Principal Investigator:||Vanessa Banz, Dr. med.||Bern University Hospital|
|Principal Investigator:||Daniel Candinas, Prof. Dr. med.||Bern University Hospital|