Background: In the US, the thermal ablation workload for cancer involving the liver is predicted to more than double in the next 5 years, emphasising the need to develop and improve the current technology.
Study design: A multicentre nonrandomised prospective clinical trial (NCT00514930) was undertaken, to assess the efficacy and safety of a new bipolar radiofrequency ablation/aspirator device, in the treatment of primary and secondary cancers of the liver.
Results: A total of 34 lesions in 16 patients were ablated at laparotomy and followed up at 4 weeks. The mean diameter of lesion before ablation was 3.2+/-2.22 (range 1-10) cm, the mean volume aspirated during ablation was 9.25+/-7.3 (range 0-25) ml and the mean operative time was 145.95+/-40.7 (range 60-215) min. There was one major complication of a pleural effusion, which required drainage. The mean length of stay was 8+/-3.2 (range 3-14) days. In 11 patients, the ablated tumour was resected. On histological assessment, there was no evidence of viable cancer at the tumour edge. On follow-up computed tomography, the ablation zone fully encompassed the targeted tumour and there were no local complications related to ablation.
Conclusion: Initial analysis of the data from this small cohort, with only a short-term follow-up, shows this device to be safe and effective.