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Clinical Application of Image-Guided Liver Surgery

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ClinicalTrials.gov Identifier: NCT00878215
Recruitment Status : Terminated (The image-guidance system became commercially available)
First Posted : April 8, 2009
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Image-guided surgery is a new technology, which is used to create 3-D pictures that generate a map of the liver. This map will allow surgeons to know the exact anatomical location of their instruments, including instances when direct visualization is not possible. This study is designed to determine the safety and feasibility of using image-guided techniques for treatment of liver tumors. The overall goal of this study is to use image-guided surgery for the improvement of the surgeon's ability to remove liver tumors.

Condition or disease Intervention/treatment Phase
Hepatocellular Cancer Device: Explorer Liver Image Guided System Device: Explorer Liver Passive Tracking Procedure: Liver surgery Procedure: Liver abalation Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Application of Image-Guided Liver Surgery
Actual Study Start Date : October 24, 2002
Actual Primary Completion Date : May 25, 2011
Actual Study Completion Date : May 25, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Phase 1:Localize Anatomical Points on Liver Surface
-The surgeon will use image-guided surgery equipment to create the mapping with 3-D pictures of the participants liver. Laser range scanning will also be used to take 3-D pictures of the liver surface. The participant will then have planned standard surgery.
Device: Explorer Liver Image Guided System Device: Explorer Liver Passive Tracking Procedure: Liver surgery
-Standard of care
Experimental: Phase 2: Ceramic bead
-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. During the surgery, a ceramic bead will be placed in a pre-operatively determined target location within the tumor using image-guided surgery. Standard surgical procedures will then be used to remove the tumors. Magnetic resonance (MR) images of the resected liver will confirm targeting accuracy.
Device: Explorer Liver Image Guided System Device: Explorer Liver Passive Tracking Procedure: Liver surgery
-Standard of care
Experimental: Phase 3: Ablative therapy
-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. The liver tumors will be ablated using image-guided surgery. Standard surgical procedures will then be used to remove the portion of the liver that has the ablated tumors. The accuracy of the ablation will be confirmed via pathology sectioning.
Device: Explorer Liver Image Guided System Device: Explorer Liver Passive Tracking Procedure: Liver surgery
-Standard of care
Procedure: Liver abalation
-Standard of care
Experimental: Phase 4: Ablative therapy (not liver resection candidates)
-This phase is for patients who otherwise do not qualify to have a portion of their liver to be surgically removed. The surgeon will use image-guidance to create the mapping with 3-D pictures of the liver. The tumors will be ablated using image-guided therapy.
Device: Explorer Liver Image Guided System Device: Explorer Liver Passive Tracking Procedure: Liver abalation
-Standard of care



Primary Outcome Measures :
  1. Number of Participants Who Have a Successful Intraoperative Registrations (Phase 1 Portion of Study) [ Time Frame: Completion of surgery ]
    • 10 successful intraoperative registrations with no more than 30% failure rate over all the cases will be considered a successful endpoint
    • A successful registration is defined as one which yields an RMS surface residual of ≤ 10 mm and is determined to be success after qualitative evaluation.

  2. Accuracy With Which Image-guided Surgery (IGS) Can be Used to Implant a Ceramic Bead Inside a Tumor as Measured by Successful Deliveries of the Bead to Within 8mm of the Pre-operatively Planned Target Point (Phase 2 Portion of Study) [ Time Frame: Completion of surgery ]
    • Calculation of bead delivery accuracy using the IGS system involves the acquisition of images of the resected specimen and then the co-registration of the post-resection images to the pre-operative image set. Given that the target location is marked in the pre-operative image set and the registration calculation allows an overlay of the two image sets a Euclidean distance error can be calculated between the true bead location and the pre-operatively determined target. Given that the error involved in computing the registration between the two image sets is included within the bead delivery target error calculation it is imperative that the impact of registration error is minimized.
    • Numbers represented are the distance between the planned target site and the true bead location

  3. Target Accuracy of an Ablation Probe Using Image-guided Surgery Technology as Measured by the Number of Participants Who Had Ablation Burns Within a 5mm Radius of the Tumor Centroid (Phase 3 Portion of Study) [ Time Frame: Completion of surgery ]
    -A measurement of the ablation probe placement via the burn zone will be performed by pathology via specimen sectioning.

  4. The Number of Participants Who Have Complete Ablation According to Early Post-ablative Imaging Studies as Well as no Recurrence of the Tumor Within 6 Months (Phase 4 Portion of the Study) [ Time Frame: 6 months post-ablation ]
    -A successful endpoint will be a 90% success rate of complete ablation according to early post-ablative imaging studies as well as no recurrence of the tumor within 6 months.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained.
  • Patient must be 18 years or older.
  • Are male or non-pregnant, non-lactating females. Liver resection or ablation could be harmful to an unborn child therefore, is not recommended during pregnancy. After informed consent is obtained, women of childbearing potential will be required to have a blood or urine pregnancy test. All consented patients of childbearing potential will be advised to use adequate birth control (oral, implanted, or barrier methods) along with their sexual partners while being considered for liver tumor resection or ablation and at least up to a month following surgery.
  • Patients enrolled in Phase I must be candidates for surgical liver resection per a treating surgeon's discretion. Patients enrolled in Phase 2-3 must be candidates for surgical liver resection of liver mass. Patients enrolled in Phase 4 must be candidates for surgical ablation, but not candidates for surgical resection.
  • Patients are scheduled clinically for use of the Pathfinder Explorer Liver Image Guided System which is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

Exclusion Criteria:

  • Any condition which, in the judgment of the investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
  • Mental condition rendering the subject or his/her legal representative unable to understand informed consent to the nature, scope, and possible consequences of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878215


Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: William C Chapman, MD Washington University School of Medicine

Additional Information:
Publications:
Horn BKP.closed-form solution of absolute orientation using unit quaternions 4:629-642,1987
Besl PM,McKay ND.A method for registraion of 3-D shapes.IEEE Transaactions on Pattern Analysis and Machine Intelligence 14:239-256,1992
Cash DM,Siha Tk,Chapman,WC.Fast, accurate surface acquistion using a laser range scanner for image-guided surgical system.SPIE Medical Imaging,2002
Pan S,Dawant BM.Automatic 3-D segmentation of the liver from abdominal CT images: a level-set approach. Proceedings of SPIE 4322:128-138,2001.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00878215     History of Changes
Other Study ID Numbers: 201104308
First Posted: April 8, 2009    Key Record Dates
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Washington University School of Medicine:
Image Guided Liver Surgery

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics