Evaluation of Image-Guided Liver Surgical System for Resection of Liver Cancer

In an automobile GPS, the current position of a vehicle is accurately localized or "registered" onto an electronic roadmap located on the dashboard. As the automobile moves, its position is updated on this roadmap. The driver can use the GPS as a guide to determine where the vehicle has been and where it is headed. This same concept is applied during image-guided surgery, as the current surgical position of instruments in the operating room is registered onto medical images of the patient acquired preoperatively. These images are used as a guide by the surgeon for more accurate localization of tumors and other surrounding anatomic structures. This clinical trial is designed to determine the effectiveness of using image-guided techniques for the treatment of liver tumors.

Inclusion criteria

• Written informed consent must be obtained.
• Patient must be 18 years or older.
• Patients recruited are male or non-pregnant, non-lactating females. Liver resection or ablation could be harmful to an unborn child, and therefore is not recommended during pregnancy. 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 one month following surgery.
• Negative serum or urine pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility).
• Patients enrolled must be candidates for surgical liver resection of liver cancer (primary or metastatic) or benign liver lesions (hemangioma, Focal Nodular Hyperplasia, Adenoma). Liver cancer must be present on preoperative imaging study (CT and/or MRI), if applicable.
• Patient must be scheduled for surgical treatment of the liver cancer requiring the removal of at least one (1) anatomic segment.

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Exclusion criteria

• 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.
• Patients that have a mental condition rendering them unable to understand informed consent to the nature, scope, and possible consequences of this study.
• Patients requiring surgical intervention that extends beyond the liver, with the exception that extension into some adjacent structures might be allowed unless the liver is not the primary focus of the surgery AND the potential blood loss from the other surgical sites may jeopardize the safety of the patient. There is no absolute rule as to what adjacent structures would be allowed, thus prior approval must be obtained from the Medical Monitor listed above for all extrahepatobiliary surgery.
• Patients with hereditary hematologic/coagulation disorders unrelated to their liver disease.
• Patients with cirrhosis of the liver classified as Child's B or C. (See Appendix A)
• Use of aspirin within 7 days prior to surgery or antiplatelet agents (i.e., Plavix) within 10 days prior to surgery or nonsteroidal anti-inflammatory medications within 48 hours prior to surgery.
• Patients with thrombocytopenia (platelet counts below 100,000 per ml, White Count 3.0, Hemoglobin 10 or greater).
• Patients who are currently (within the last 30 days prior to surgery) participating in another clinical trial with any investigational drug or device.
• Patients undergoing liver surgery as a result of trauma.
• Patients undergoing liver surgery for the purpose of receiving a liver transplant.
• Patients undergoing liver surgery in which there is a single minor wedge resection on the surface of the liver.
• Patients with established renal insufficiency (defined as creatinine greater than 2.5 mg/dl), or a condition that requires hemodialysis.

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