Clinical Application of Image-Guided Liver Surgery

The Washington University

Status and phase: Terminated; Phase 2

Conditions: Hepatocellular Cancer

Treatments: Procedure: Liver surgery; Procedure: Liver abalation; Device: Explorer Liver Passive Tracking; Device: Explorer Liver Image Guided System

Study type: Interventional

Funder types: Other

Identifiers

NCT00878215

201104308

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Phase 1:Localize Anatomical Points on Liver Surface

Experimental group

Description:

-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.

Treatment:

Device: Explorer Liver Image Guided System

Device: Explorer Liver Passive Tracking

Procedure: Liver surgery

Phase 2: Ceramic bead

Experimental group

Description:

-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.

Treatment:

Device: Explorer Liver Image Guided System

Device: Explorer Liver Passive Tracking

Procedure: Liver surgery

Phase 3: Ablative therapy

Experimental group

Description:

-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.

Treatment:

Device: Explorer Liver Image Guided System

Device: Explorer Liver Passive Tracking

Procedure: Liver abalation

Procedure: Liver surgery

Phase 4: Ablative therapy (not liver resection candidates)

Experimental group

Description:

-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.

Treatment:

Device: Explorer Liver Image Guided System

Device: Explorer Liver Passive Tracking

Procedure: Liver abalation