A Randomized Controlled Trial of Resection Versus Thermal Ablation of Colorectal Cancer Liver Metastases (New Comet): Study Protocol.

Abstract

The use of thermal ablation of liver tumors is rapidly increasing. This is despite a lack of high-level evidence of the oncologic efficacy of ablation. Ablation is most often used in cases where resection is not possible, but as the technique has improved it is increasingly used as a substitute for resection. New Comet is an international multicenter randomized controlled double-blinded, non-inferiority trial comparing thermal ablation to resection of colorectal liver metastases. It will include 230 patients with colorectal liver metastases (up to 5 lesions, tumor size up to 3 cm) where thermal ablation and resection both are considered suitable treatment options for all lesions. The patients are randomized to either resection or ablation, and all lesions in each patient are treated with the same modality. Complete ablation will be verified with intraoperative computed tomography and ablation confirmation software. The primary endpoint is local tumor recurrence at 12 months. Secondary endpoints include overall survival, disease-free survival, time to surgical failure, health-related quality of life, complications, and cost-effectiveness (trial registration no.: NCT05129787).