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A Prospective, Non Randomized Study

18 Years
Open (Enrolling)
Adult Liver Cancer

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Trial Information

A Prospective, Non Randomized Study


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


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).

Inclusion Criteria:

- 1.Written informed consent

- 2.Male patients and non-pregnant, non-lactating females aged ≥18 years of age
(negative serum/urine pregnancy test result at screening)

- 3.Patients must be candidates for surgical liver resection and/or MWA (at least one
anatomical segment) of primary or metastatic liver cancer. The liver tumors must be
present on preoperative imaging study (CT and/or MRI).

Exclusion Criteria

- 1.Any condition which, in the judgment of the clinical investigator or his designee,
might increase the risk to the subject or decrease the chance of obtaining
satisfactory data to achieve the objectives of the study.

- 2.A mental condition rendering the patient unable to provide informed consent.

- 3.Patients with hereditary hematological / coagulation disorders unrelated to their
liver disease or cirrhosis of the liver classified as Child's B or C.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

TRE, measuring the error in the prediction of a surgical target location when using the navigation system.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Vanessa Banz, Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bern University Hospital


Switzerland: Independent Local Research Ethic Commission (Ethikkommission)

Study ID:




Start Date:

October 2011

Completion Date:

December 2013

Related Keywords:

  • Adult Liver Cancer
  • prospective study
  • multicenter trial
  • analysis, computer assisted image
  • CE marked
  • medical devices
  • catheter ablation
  • Liver Neoplasms
  • Carcinoma, Hepatocellular