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A prospective randomized study comparing radiofrequency ablation and hepatic resection for hepatocellular carcinoma.

ABSTRACT: Purpose:Although there are several prospective clinical studies comparing radiofrequency ablation (RFA) and hepatic resection (HR) for the treatment of hepatocellular carcinoma, there are few trials that have been performed in strictly homogeneous patients. Methods:Patients who were newly diagnosed with a solitary hepatocellular carcinoma were randomized to the HR or RFA group. Inclusion criteria were as follows: age ? 20 years but ? 70 years, Child-Pugh class A, maximal diameter of the tumor ? 2 cm but ? 4 cm, no previous treatment history, and platelet count > 80,000/mm3. Results:Although the study was early terminated, 29 and 34 patients were enrolled in the HR and RFA groups, respectively, and prospectively followed on an intention-to-treat basis. The 5-year overall survival rates were 83.4% and 86.2% in the HR and RFA groups, respectively, which were not significantly different (P = 0.812 by log-rank, P = 0.990 by Breslow). The 3- and 5-year disease-free survival rates in the HR group were significantly superior to those in the RFA group (66.7%, 44.4% vs. 44.1%, 31.2%, P = 0.071 by log-rank, P = 0.023 by Breslow). Intrahepatic local recurrence tended to develop more frequently in the RFA group (P = 0.042), while the frequency of intrahepatic distant and extrahepatic recurrence was similar bet ween the 2 groups. There were no significant differences in the frequency and severity of complications between the 2 groups. Conclusion:HR was significantly superior to RFA in terms of disease-free survival; however, the overall survival was excellent in both groups.

SUBMITTER: Lee HW

PROVIDER: S-EPMC5801331 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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A prospective randomized study comparing radiofrequency ablation and hepatic resection for hepatocellular carcinoma.

Lee Hae Won HW Lee Jeong Min JM Yoon Jung-Hwan JH Kim Yoon Jun YJ Park Joong-Won JW Park Sang-Jae SJ Kim Seong Hoon SH Yi Nam-Joon NJ Suh Kyung-Suk KS

Annals of surgical treatment and research 20180130 2

<h4>Purpose</h4>Although there are several prospective clinical studies comparing radiofrequency ablation (RFA) and hepatic resection (HR) for the treatment of hepatocellular carcinoma, there are few trials that have been performed in strictly homogeneous patients.<h4>Methods</h4>Patients who were newly diagnosed with a solitary hepatocellular carcinoma were randomized to the HR or RFA group. Inclusion criteria were as follows: age ≥ 20 years but ≤ 70 years, Child-Pugh class A, maximal diameter ...[more]

PMID: 29441336

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Project description:It remains controversial whether surgical resection, compared to radiofrequency ablation (RFA), improves overall survival (OS) in patients with early hepatocellular carcinoma (HCC). This study aimed to compare OS after RFA with that after resection for HCC. This retrospective study included patients who underwent RFA or surgical resection as initial treatment for hepatitis B virus (HBV)-related HCC at a very early or early stage. A total of 761 patients (RFA, n = 194; resection, n = 567) from Seoul National University Hospital (Seoul, South Korea) and 1277 patients (RFA, n = 352; resection, n = 925) from the Korean Primary Liver Cancer Registry were included in the hospital and nationwide cohorts, respectively. Primary and secondary endpoints were OS and recurrence-free survival (RFS), respectively. Additional analysis was performed when the history of the antiviral treatment and the type of prescribed nucleos(t)ide analogue were confirmed. The rate of complications was compared between the two treatment groups in the hospital cohort. Baseline characteristics were balanced, using inverse probability of treatment weighting (IPTW). In the hospital cohort, the RFA group had a smaller mean tumor size (1.7 vs. 3.9 cm) but a higher proportion of cirrhotic patients than the resection group (85.6% vs. 63.1%) (both p < 0.01). During 81.0 (interquartile range, 62.3-107.1) months of follow-up, there was no difference in OS (adjusted hazard ratio (aHR) = 0.870, 95% confidence interval (CI) = 0.400-1.897, p = 0.73) and RFA was associated with shorter RFS (aHR = 1.562, 95% CI = 1.099-2.219, p = 0.01) after employing IPTW. Antiviral treatment was independently associated with longer OS (aHR = 0.444, 95% CI = 0.251-0.786, p = 0.01) as well as RFS (aHR = 0.544, 95% CI = 0.391-0.757, p < 0.01) in the hospital cohort. In the nationwide cohort, there was no difference in OS (aHR = 0.981, 95% CI = 0.661-1.456, p = 0.92) between the two treatment groups when adjusted for antiviral treatment, which was a negative independent risk factor for mortality (aHR = 0.655, 95% CI = 0.451-0.952, p = 0.03) after IPTW. Among patients treated with tenofovir (n = 96) or entecavir (n = 184) in the hospital cohort, there was no difference in either OS (aHR = 0.522, 95% CI = 0.058-4.724, p = 0.56) or RFS (aHR = 1.116, 95% CI = 0.738-1.688, p = 0.60). The overall incidence of complications was higher in the resection group (26.3%) than in the RFA group (13.9%) (p < 0.01). RFA may provide comparable OS to resection in the treatment of very early or early HCC with a lower rate of complications, although RFS is marginally shorter than in the resection group after adjusting for antiviral treatment. Regardless of the type of NA, antiviral treatment in patients with HBV-related HCC is strongly associated with both OS and RFS.

Project description:ObjectiveThis study aimed to compare the efficacy between bipolar radiofrequency ablation (RFA), using twin internally cooled wet (TICW) electrodes, and switching monopolar RFA, using separable clustered (SC) electrodes, in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.Materials and methodsIn this single-center, two-arm, parallel-group, randomized controlled study, we performed a 1:1 random allocation on eligible patients with recurrent HCC after locoregional treatment, to receive TICW-RFA or SC-RFA. The primary endpoint was the minimum diameter of the ablation zone per unit ablation time. Secondary endpoints included other technical parameters, complication rate, technical success and technique efficacy, and clinical outcomes.ResultsEnrolled patients were randomly assigned to the TICW-RFA group (n = 40) or SC-RFA group (n = 37). The two groups did not show significant differences in the primary endpoint, the minimum diameter of the ablation zone per unit ablation time was 2.71 ± 0.98 mm/min and 2.61 ± 0.96 mm/min in the TICW-RFA and SC-RFA groups, respectively (p = 0.577). Total RF energy delivery (11.75 ± 9.04 kcal vs. 22.61 ± 12.98 kcal, p < 0.001) and energy delivery per unit time (0.81 ± 0.49 kcal/min vs. 1.45 ± 0.42 kcal/min, p < 0.001) of the TICW-RFA group were less than those of the SC-RFA group. No procedure-related death or major complications occurred. Technical success was achieved in all patients in both groups, and technique efficacy rates were 100% (46/46) in the TICW-RFA group and 95.0% (38/40) in the SC-RFA group (p = 0.213). The 1-year and 2-year cumulative LTP rates were 11.8% and 24.2%, respectively, in the TICW-RFA group, and 8.6% and 18.1%, respectively, in the SC-RFA group (p = 0.661).ConclusionIn this single-center randomized controlled study from a Korean tertiary referral hospital, TICW-RFA demonstrated similar therapeutic efficacy and safety profile for recurrent HCC after locoregional treatment compared with SC-RFA.Trial registrationClinicalTrials.gov (NCT03806218).

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A prospective randomized study comparing radiofrequency ablation and hepatic resection for hepatocellular carcinoma.

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A prospective randomized study comparing radiofrequency ablation and hepatic resection for hepatocellular carcinoma.

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