Authors' objectives:

To evaluate the efficacy, safety and cost-effectiveness of radiofrequency ablation in the treatment of primary and secondary hepatic tumours considering the scientific evidence available.

Authors' results and conclusions: 80 articles were identified and analysed (5 RCTs, 75 observational studies). In general, the studies displayed considerable methodological limitations and evidence was limited by the number and variety of techniques and devices currently in use, type of patients included, small sample size, short follow-up times and a lack of comparability between the outcome measures. Regarding efficacy the literature shows a highly variable rate of complete ablation (48% to 100%) and local recurrence rates, from 0% to 45%. Average one year survival is about 90% (range: 60-100%), but long-term survival rates have not yet been established. With respect to safety the overall morbidity reported is around 12% (0-27%) with a low mortality rate (0.09-0.3%). Comparisons showed a greater efficacy of RFA in terms of the proportion of complete necrosis, recurrence rate and number of procedures needed than percutaneous ethanol injection, microwave coagulation therapy and cryotherapy. Conversely, as compared with resection RFA shows a higher rate of recurrence and a decreased time interval to recurrence. RFA seems to be safer than microwave coagulation therapy and cryotherapy but shows a higher complication rate than percutaneous ethanol injection. Additionally, percutaneous RFA has been shown to be cost-effective when compared with palliative treatments for both HCC and liver metastases.

Authors' recommendations: This report identified a body of comparative and non-comparative studies indicating that RFA is a relatively safe and promising technique that may be effective as a component of multimodality treatment for unresectable hepatic tumours. However, experience with RFA is not yet mature enough to establish long-term outcomes. Additionally there are a number of uncertainties surrounding some aspects of this technology that need to be clarified including: the appropriate indications, best technical approach, control of potential complications, image-guided follow-up, long-term outcomes and organizational issues.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.isciii.es/aets

Year Published: 2004

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Agencia de Evaluacion de Tecnologias Sanitarias

Contact Address: Instituto de Salud "Carlos III", Calle Sinesio Delgado 6, Pabellon 4, 28029 Madrid, Spain. Tel: +34 9 1 822 2005; Fax: +34 9 1 387 7841;

Contact Name: Luis M. Sánchez Gómez

Contact Email: luism.sanchez@isciii.es

Copyright: Agencia de Evaluacion de Tecnologias Sanitarias (AETS)