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CompletedNCT01474694CALSUpdated Nov 26, 2015

Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver

An observational study in Adult Liver Cancer, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-26.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
14
Ages
18 Years and older
Sex
All
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Study summary

Preoperative image-guided data correlates with the actual intraoperative reality. Computer-assisted preoperative planning combined with intraoperative mapping of even very small lesions allows for improved accuracy during complete oncological resection / ablation. In the short- and long-term this possibly results in better patient outcome.

Read the detailed description

Background

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.

Objective

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

Methods

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).

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Conditions studied

  • Adult Liver Cancer

Keywords

  • prospective study
  • multicenter trial
  • analysis, computer assisted image
  • CE marked
  • medical devices
  • catheter ablation
03

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's enrollment of 14 is below the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients that are still considered unresectable at the time point of presentation

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
14 participants (actual)
Patient registry
No

Interventions

  • OtherAbdominal surgery

    The patient is placed in a supine position and standard laparotomy (either via subcostal, midline or inverted hockey-stick incision) is performed. After mobilization of the liver, surgical swabs are packed around the organ to prevent unnecessary movement of the liver during the acquisition of the landmarks and the subsequent surgical procedure

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What researchers measure

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. 1.Identification of suitable landmarks for registration

    Time frame: 15 months

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Study locations

1 site
  • Dep. of visceral and Transplant Surgery, Bern University Hospital
    Berne, 3010, Switzerland
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References and documents

Publications

  • Peterhans M, vom Berg A, Dagon B, Inderbitzin D, Baur C, Candinas D, Weber S. A navigation system for open liver surgery: design, workflow and first clinical applications. Int J Med Robot. 2011 Mar;7(1):7-16. doi: 10.1002/rcs.360. Epub 2010 Oct 29. PubMed 21341357 ↗
  • Gavaghan KA, Peterhans M, Oliveira-Santos T, Weber S. A portable image overlay projection device for computer-aided open liver surgery. IEEE Trans Biomed Eng. 2011 Jun;58(6):1855-64. doi: 10.1109/TBME.2011.2126572. Epub 2011 Mar 14. PubMed 21411401 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01474694
Lead sponsor
Insel Gruppe AG, University Hospital Bern
First posted
Nov 18, 2011
Start date
Oct 2011
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Nov 26, 2015

Study contacts

Vanessa Banz, Dr. med.
principal investigator · Bern University Hospital
Daniel Candinas, Prof. Dr. med.
principal investigator · Bern University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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