Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver (CALS)
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ClinicalTrials.gov Identifier: NCT01474694 |
Recruitment Status
:
Completed
First Posted
: November 18, 2011
Last Update Posted
: November 26, 2015
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Tracking Information | |||||||
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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 |
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 |
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). |
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Study Type | Observational | ||||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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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 |
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Study Groups/Cohorts | Not Provided | ||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
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:
Exclusion Criteria
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Sex/Gender |
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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 |
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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 |
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PRS Account | University Hospital Inselspital, Berne | ||||||
Verification Date | November 2015 |