Background: High intensity focused ultrasound (HIFU) is a recent, non-ionizing and non invasive technology of focal destruction. Independence from perfusion makes HIFU a promising technique for focal ablation of liver tumours.Current technology is based on extra-corporeal treatment which limits use of HIFU for the treatment of liver tumours. Moreover elementary ablations are small and must be juxtaposed to treat supra-centimetric tumours, resulting in long-time treatment. Methods: We developed an HIFU probe for intra-operative use and assessed the feasibility and efficacy of this device in patients with colorectal liver metastases (< 20mm). This study was a prospective, single-centre phase I/II study. All ablations were performed in the area of liver scheduled for liver resection to avoid loss of chance. Results: Twenty-eight patients were included. HIFU ablations were created to ablate metastases with safety margins in all directions. The exposure time varied from 40 seconds to 370 seconds according to the diameter of the metastases to be treated. One metastasis of 10 mm in diameter was ablated in 40 seconds with safety margins. Using electronic focusing metastases of 2 cm in diameter were ablated with safety margins (> 3 mm in all directions) in 370 seconds. The dimensions of these HIFU ablations were a diameter of 48 AE 4.9 mm and a long axis of 51 AE 3.4 mm. No damage occurred to neighboring tissues. Conclusion: Intra-operative HIFU can produce ablations of 5 centimeters in 6 minutes with a precision of 1-2mm and real-time monitoring (NCT01489787)
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