Cryosurgical ablation (CSA) is a procedure that destroys target tissue by freezing, most often by inserting a probe through which coolant is circulated into the tumor. CSA can be performed as an open surgical technique or percutaneously or laparoscopically, typically with ultrasound guidance.
For individuals with unresectable primary hepatocellular carcinoma amenable to locoregional therapy, the evidence includes a randomized controlled trial, several nonrandomized comparative studies, and multiple noncomparative studies. Reported outcomes of interest include overall survival, disease-specific survival, and treatment-related mortality and morbidity. Although one randomized trial showed lower local tumor progression with cryoablation compared with radiofrequency ablation, there were no differences in survival outcomes and trial limitations mean findings require replication. Additional comparative evidence is needed to draw conclusions about the effectiveness of cryoablation compared with other locoregional therapies.
For individuals with unresectable liver metastases from neuroendocrine tumors or from colorectal cancer amenable to locoregional therapy, the evidence base is limited to systematic reviews, nonrandomized studies, and case series. Available randomized and comparative studies have methodological limitations and potential selection bias. Overall, the evidence is limited and inconsistent for both primary hepatocellular carcinoma and for liver metastases from neuroendocrine or colorectal cancer.
Because available studies do not demonstrate consistent benefits in key outcomes such as overall survival or disease-specific survival and because comparative data are limited and at risk of bias, the evidence is insufficient to determine the effects of CSA on health outcomes for unresectable primary hepatocellular carcinoma or for liver metastases. As a result, cryosurgical ablation of liver tumors is not covered / not medically necessary under the products addressed by this policy.