Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver (CALS)

Tracking Information
First Submitted Date	November 15, 2011
First Posted Date	November 18, 2011
Last Update Posted Date	November 26, 2015
Study Start Date	October 2011
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: November 17, 2011)	TRE, measuring the error in the prediction of a surgical target location when using the navigation system. [ Time Frame: 12 months ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01474694 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: November 17, 2011)	1.Identification of suitable landmarks for registration [ Time Frame: 15 months ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver
Official Title	Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver: A Prospective, Non Randomized Study
Brief 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.
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).
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	patients that are still considered unresectable at the time point of presentation
Condition	Adult Liver Cancer
Intervention	Other: Abdominal 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
Study Groups/Cohorts	Not Provided
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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: November 17, 2011)	14
Original Estimated Enrollment	Same as current
Actual Study Completion Date	December 2013
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Switzerland
Removed Location Countries
Administrative Information
NCT Number	NCT01474694
Other Study ID Numbers	063/11; Eureka 6201/5/Ae
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dr.med. Vanessa Banz/ Prof. Dr. med.Daniel Candinas, Bern University Hospital
Study Sponsor	University Hospital Inselspital, Berne
Collaborators	Not Provided
Investigators	Principal Investigator: Vanessa Banz, Dr. med. Bern University Hospital Principal Investigator: Daniel Candinas, Prof. Dr. med. Bern University Hospital
PRS Account	University Hospital Inselspital, Berne
Verification Date	November 2015