Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)

Primary Objective:

To evaluate the technical efficacy and Local Tumor Progression-free survival [LTPFS] of a high-precision liver ablation technique comprised by stereotactic-guidance, CT during hepatic arteriography-based imaging analysis, and computer-based software assessment of ablation margins, for the treatment of patients with colorectal liver metastasis referred to percutaneous liver ablation.

Secondary Objectives:

To evaluate the impact of this high-precision liver ablation technique on:

• Impact of minimally ablated margins on LTPFS
• 3D Minimal ablation margins;
• Adverse events;
• Liver function;
• Tissue properties from US elastography;
• Contrast-media utilization and radiation exposure;
• Overall oncological outcomes (disease-free and overall survival, and ability to provide salvage local therapy at the time of recurrence).
• Anesthesia/procedural time
• Response and Duration of response
• Assessing whether ringenhancing hypervascular liver micronodules represent metastasis

Inclusion criteria

• Patients presenting with up to 5 colorectal liver metastasis measuring up to 5 cm who are referred to percutaneous ablation;
• Ability to completely cover the target tumor with at least a 5 mm ablation margin as determined per pre-procedure cross-sectional imaging;
• Distance to central bile ducts > 1 cm;
• Adequate glomerular filtration rate (GFR > 40) and no severe allergies to iodine contrast-media;
• Ability to understand and the willingness to sign written informed consent;
• Age > 18 years-old;
• Performance status 0-2 (Eastern Cooperative Oncology Group Classification [ECOG]);
• Expected survival > 12 months.

Exclusion criteria

• Use of other prior or concomitant local therapy at the target tumor(s).
• Active bacterial infection or fungal infection on the day of the ablation.
• Platelet < 50,000/mm3.
• INR > 1.5
• Patients with uncorrectable coagulopathy.
• Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
• Physical or psychological condition which would impair study participation.
• ASA (American Society of Anesthesiologists) score of ≥ 4.
• Any other loco-regional therapies at the target lesion(s).
• Anatomical variations in the arterial-hepatic blood supply of the liver that preclude the use of CTHA imaging.