Clinical Application of Image Guided Liver Surgery
This study is currently recruiting participants.
Verified October 2011 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00878215
First received: April 7, 2009
Last updated: October 6, 2011
Last verified: October 2011
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Purpose
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 | Intervention |
|---|---|
|
Hepatocellular Cancer |
Procedure: Phase 1-4,To localize anatomical points on the liver surface |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Application of Image Guided Liver Surgery |
Resource links provided by NLM:
Further study details as provided by Washington University School of Medicine:
Primary Outcome Measures:
- To reach success in complete ablation of liver cancer tumors as well as no recurrence of the tumor within 6 months. [ Time Frame: no recurrence of tumor within 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The accuracy of image-guided surgery and laser range scanning in hepatic surgery [ Time Frame: completion of surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 66 |
| Study Start Date: | December 2002 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phase 1
The objective of phase 1 is to localize anatomical points on the liver surface using image-guided surgery and laser range scanning. The specific endpoint of this phase will be reached when we perform 10 successful intraoperative registrations with no more than a 30% failure rate over all the cases.
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Procedure: Phase 1-4,To localize anatomical points on the liver surface
The next phase of each study will not begin enrolling subjects until the previous phase is over. If the objectives of any phase are not met, then the study will be discontinued and postponed and the experimental protocol will be revised.
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|
Experimental: Phase 2
The objective of phase 2 is to implant a steel bead inside a tumor using image-guided surgery (IGS) with accuracy similar to conventional guidance methods using intraoperative ultrasound (IOUS). After the steel bead is implanted using IGS or IOUS, the tumor will be removed with standard surgical resection methods and analyzed using imaging and pathology. If we are unable to insert the steel bead due to technical or anatomical difficulty, we will consider this a screen failure.
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Procedure: Phase 1-4,To localize anatomical points on the liver surface
The next phase of each study will not begin enrolling subjects until the previous phase is over. If the objectives of any phase are not met, then the study will be discontinued and postponed and the experimental protocol will be revised.
|
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Experimental: phase 3
The objective of phase 3 is to target an ablation probe using image-guided surgery methods with the same accuracy as conventional targeting methods. After the ablation procedure, tumors will be removed with standard resection procedures and analyzed using imaging and pathology. The specific endpoint of this study is to achieve complete ablation with ≥ 1cm resection margin surrounding the tumor as confirmed by pathology assessment.
|
Procedure: Phase 1-4,To localize anatomical points on the liver surface
The next phase of each study will not begin enrolling subjects until the previous phase is over. If the objectives of any phase are not met, then the study will be discontinued and postponed and the experimental protocol will be revised.
|
|
Experimental: Phase 4
The objective of Phase 4 is to perform ablation using image-guided surgery on tumors within patients who are not candidates for standard surgical resection. The specific endpoint is to reach 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.
|
Procedure: Phase 1-4,To localize anatomical points on the liver surface
The next phase of each study will not begin enrolling subjects until the previous phase is over. If the objectives of any phase are not met, then the study will be discontinued and postponed and the experimental protocol will be revised.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
- 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
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878215
Contacts
| Contact: William C Chapman, MD | 314-362-2538 | chapmanw@wustl.edu |
| Contact: Helen E Kaemmerer, BS,CCRC | 314-362-3791 | kaemmererh@wudosis.wustl.edu |
Locations
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: William C Chapman, MD 314-362-2538 chapmanw@wudosis.wustl.edu | |
| Principal Investigator: William C Chapman, MD | |
Sponsors and Collaborators
Washington University School of Medicine
Investigators
| Principal Investigator: | William C Chapman, MD | Washington University Medical School |
More Information
Publications:
Besl PM,McKay ND.A method for registraion of 3-D shapes.IEEE Transaactions on Pattern Analysis and Machine Intelligence 14:239-256,1992
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: | 02-0836 |
| Study First Received: | April 7, 2009 |
| Last Updated: | October 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
Image Guided Liver Surgery |
Additional relevant MeSH terms:
|
Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 22, 2013