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J Gastroenterol. 2013 Jul;48(7):874-83. doi: 10.1007/s00535-012-0685-x. Epub 2012 Oct 10.

Clinical effectiveness of bipolar radiofrequency ablation for small liver cancers.

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  • 1Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan.

Erratum in

  • J Gastroenterol. 2013 Nov;48(11):1308-9.

Abstract

BACKGROUND:

Radiofrequency ablation (RFA) is minimally invasive and can achieve a high rate of cure of liver cancer. This study was conducted to evaluate the efficacy and safety of a bipolar RFA device (CelonPOWER System) in the treatment of Japanese liver cancer patients.

METHODS:

The study was a multicenter, single-group, open-label trial. The indications for RFA were based on the Japanese guidelines for the management of liver cancer. The subjects had a Child-Pugh classification of A or B, and the target tumors were defined as nodular, numbering up to 3 lesions, each of which was 3 cm or less in diameter, or solitary lesions up to 4 cm in diameter. To test for the non-inferiority of the CelonPOWER System, this system was compared with the Cool-tip RF System, which has already been approved in Japan, in terms of the complete necrosis rate (CNR).

RESULTS:

The CNR obtained with the CelonPOWER System was 97.8 % (88/90 patients). The CNR obtained with the Cool-tip RF System was 86.2 % (50/58 patients), confirming the non-inferiority of the CelonPOWER System (p < 0.001, Fisher's exact test based on binomial distribution). Throughout the treatment and follow-up periods, there were no adverse events regarding safety that were uniquely related to the CelonPOWER System and there were no cases of device failure.

CONCLUSIONS:

The CelonPOWER System was confirmed to be an effective and safe RFA device. It could become extensively used as a safe next-generation RFA device, reducing the physical burden on patients.

PMID:
23053425
[PubMed - indexed for MEDLINE]
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