Feng K, Yan J, Li X, et al. A randomized controlled trial of radiofrequency ablation and surgical resection in the treatment of small hepatocellular carcinoma

Institute of Combined Injury, State Key Laboratory of Trauma, Burns and Combined Injury, Chongqing Engineering Research Center for Nanomedicine, College of Preventive Medicine, Third Military Medical University, Chongqing, 400038, China
Journal of Hepatology (Impact Factor: 11.34). 05/2012; 57(4):794-802. DOI: 10.1016/j.jhep.2012.05.007
Source: PubMed


The aim of this study was to compare the efficacy of radiofrequency ablation (RFA) with surgical resection (RES) in the treatment of small hepatocellular carcinoma (HCC).
A total of 168 patients with small HCC with nodular diameters of less than 4cm and up to two nodules were randomly divided into RES (n=84) and RFA groups (n=84). Outcomes were carefully monitored and evaluated during the 3-year follow-up period.
The 1-, 2-, and 3-year survival rates for the RES and RFA groups were 96.0%, 87.6%, 74.8% and 93.1%, 83.1%, 67.2%, respectively. The corresponding recurrence-free survival rates for the two groups were 90.6%, 76.7%, 61.1% and 86.2%, 66.6%, 49.6%, respectively. There were no statistically significant differences between the two groups in overall survival rate (p=0.342) or recurrence-free survival rate (p=0.122). Multivariate analysis demonstrated that the independent risk factors associated with survival were multiple occurrences of tumors at different hepatic locations (relative risk of 2.696; 95% CI: 1.189-6.117; p=0.018) and preoperative indocyanine green retention rate at 15min (ICG-15) (relative risk of 3.853; 95% CI: 1.647-9.015; p=0.002).
In patients with small hepatocellular carcinomas, percutaneous RFA may provide therapeutic effects similar to those of RES. However, percutaneous RFA is more likely to be incomplete for the treatment of small HCCs located at specific sites of the liver, and open or laparoscopic surgery may be the better choice.

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    • "The authors chose this experimental design to prevent the withdrawals of patients to be treated by radiofrequency ablation while surgery was the standard treatment.26 According to the flow chart, four patients refused to participate in the trial.26 After randomization, the number of patients refusing the proposed treatment was well balanced, four in the radiofrequency group and four in the surgery group.26 "
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    ABSTRACT: Clinical evidence available for the assessment of medical devices (MDs) is frequently insufficient. New MDs should be subjected to high quality clinical studies to demonstrate their benefit to patients. The randomized controlled trial (RCT) is the study design reaching the highest level of evidence in order to demonstrate the efficacy of a new MD. However, the clinical context of some MDs makes it difficult to carry out a conventional RCT. The objectives of this review are to present problems related to conducting conventional RCTs and to identify other experimental designs, their limitations, and their applications. A systematic literature search was conducted for the period January 2000 to July 2012 by searching medical bibliographic databases. Problems related to conducting conventional RCTs of MDs were identified: timing the assessment, eligible population and recruitment, acceptability, blinding, choice of comparator group, and learning curve. Other types of experimental designs have been described. Zelen's design trials and randomized consent design trials facilitate the recruitment of patients, but can cause ethical problems to arise. Expertise-based RCTs involve randomization to a team that specializes in a given intervention. Sometimes, the feasibility of an expertise-based randomized trial may be greater than that of a conventional trial. Cross-over trials reduce the number of patients, but are not applicable when a learning curve is required. Sequential trials have the advantage of allowing a trial to be stopped early depending on the results of first inclusions, but they require an independent committee. Bayesian methods combine existing information with information from the ongoing trial. These methods are particularly useful in situations where the number of subjects is small. The disadvantage is the risk of including erroneous prior information. Other types of experimental designs exist when conventional trials cannot always be applied to the clinical development of MDs.
    Full-text · Article · Sep 2014 · Medical Devices: Evidence and Research
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    • "Treatment of liver tumors has developed from radical surgery to comprehensive multidisciplinary treatment, involving surgery, intervention and chemotherapy (7). For HCC of small foci (diameter, <4 cm), the RFA method has the same result as surgical resection (8). Rossi et al were the first to successfully use RFA to treat liver tumors clinically (9). "
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    ABSTRACT: Radiofrequency ablation (RFA) is a minimally invasive technique used to treat liver tumors. The current study presents the case of a patient with hepatocellular carcinoma who suffered from post-operative pericardial effusion following RFA treatment. We hypothesize that RFA thermal conduction may damage the diaphragm and pericardium, leading to local edema in the pericardium. RFA is a minimally invasive technique, however, adequate preparatory work must be performed prior to surgery, including a comprehensive assessment of the patient. During surgery, the location and extent of the region to receive RFA must be determined precisely in order to reduce the range of damage and to avoid post-operative complications. This study describes a case of pericardial effusion caused by RFA of liver cancer. We analyzed the causes and preventive measures for pericardial effusion in order to contribute to the prevention pericardial effusion that is complicated by RFA of liver cancer.
    Full-text · Article · Feb 2014 · Oncology letters
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    • "In the last decade, a number of retrospective and randomized controlled trials (RCTs) which directly compared these two treatments have been published. Available RCTs have not resolved the doubts regarding the superiority of one treatment over the other, probably due to the inclusion criteria adopted [4] [5] [6]. Observational studies have not helped to clarify this topic since they have clearly shown that the patients undergoing HR or RFA were significantly different as regards the clinical and tumoral characteristics capable of affecting prognosis [7] [8] [9] [10] [11] [12] [13] [14] [15] [16]; if all these biases are not adequately handled, the results can be confounding. "
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    ABSTRACT: Whether to prefer hepatic resection or radiofrequency ablation as first line therapy for hepatocellular carcinoma is a matter of debate. To compare outcomes of resection and ablation, in the treatment of early hepatocellular carcinoma, through a decision-making analysis. Data of 388 cirrhotic patients undergoing resection and of 207 undergoing radiofrequency ablation were reviewed. Two distinct regression models were devised and used to perform sensitivity and probabilistic analyses, to overcome biases of covariate distributions. Actuarial survival curves showed no difference between resection and ablation (P=0.270) despite the fact that ablated patients were older, with worse liver function and smaller, unifocal tumours (P<0.05), suggesting a complex, non-linear relationship between clinical, tumoral variables and treatments. Sensitivity and probabilistic analyses suggested that the superiority of resection over ablation decreased at higher Model for-End stage Liver Disease scores, and that ablation provided better results for smaller tumours and higher Model for-End stage Liver Disease scores. In patients with 2-3 tumours up to 3cm, the two treatments produced opposite comparative results in relation to the Model for-End stage Liver Disease score. The superiority, or the equivalence, of resection and ablation depends on the non-linear relationship existing between treatment, tumour number, size and degree of liver dysfunction.
    Full-text · Article · Nov 2013 · Digestive and Liver Disease
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