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.
Project description:Background:Due to the heterogeneity of patients with Barcelona clinic liver cancer (BCLC) intermediate-stage hepatocellular carcinoma (HCC), Bolondi criteria were proposed and patients were divided into four substages. The purpose of this study was to compare the survival of substage B1 patients who were initially treated with a combination of transarterial chemoembolization (TACE) and radiofrequency ablation (RFA) (TACE-RFA) or TACE alone. Methods:404 patients with stage B1 HCC were retrospectively analyzed from January 2005 to December 2012. 209 patients received TACE-RFA, and 195 received TACE alone as initial treatment. The overall survival (OS) and progression-free survival (PFS) rates were estimated by the Kaplan-Meier method and compared by the log-rank test. Results:1-, 3-, and 5-year OS rates were 83.7%, 45.8%, and 24.8% in the TACE-RFA group and 80.7%, 26.4%, and 16.7% in the TACE group, respectively (P=0.003). The corresponding PFS rates were 71.8%, 26.6%, and 13.0% and 59.1%, 11.0%, and 2.2% in the TACE-RFA group and TACE group, respectively (P < 0.001). Multivariate regression analysis indicated that tumor size (OS: hazard ratio (HR)?=?0.683, P=0.001; PFS: HR?=?0.761, P=0.013), along with treatment allocation (OS: HR?=?0.701, P=0.003; PFS: HR?=?0.620, P < 0.001), was the independent prognostic factor for both OS and PFS. Conclusions:Combination TACE and RFA treatment yielded better survival than TACE alone for patients with stage B1 HCC according to the Bolondi criteria.
Project description:<h4>Objective</h4>This study aimed to compare the efficacy between no-touch (NT) radiofrequency ablation (RFA) and conventional RFA using twin internally cooled wet (TICW) electrodes in the bipolar mode for the treatment of small hepatocellular carcinomas (HCC).<h4>Materials and methods</h4>In this single-center, two-arm, parallel-group, prospective randomized controlled study, we performed a 1:1 random allocation of eligible patients with HCCs to receive NT-RFA or conventional RFA between October 2016 and September 2018. The primary endpoint was the cumulative local tumor progression (LTP) rate after RFA. Secondary endpoints included technical conversion rates of NT-RFA, intrahepatic distance recurrence, extrahepatic metastasis, technical parameters, technical efficacy, and rates of complications. Cumulative LTP rates were analyzed using Kaplan-Meier analysis and the Cox proportional hazard regression model. Considering conversion cases from NT-RFA to conventional RFA, intention-to-treat and as-treated analyses were performed.<h4>Results</h4>Enrolled patients were randomly assigned to the NT-RFA group (37 patients with 38 HCCs) or the conventional RFA group (36 patients with 38 HCCs). Among the NT-RFA group patients, conversion to conventional RFA occurred in four patients (10.8%, 4/37). According to intention-to-treat analysis, both 1- and 3-year cumulative LTP rates were 5.6%, in the NT-RFA group, and they were 11.8% and 21.3%, respectively, in the conventional RFA group (<i>p</i> = 0.073, log-rank). In the as-treated analysis, LTP rates at 1 year and 3 years were 0% and 0%, respectively, in the NT-RFA group sand 15.6% and 24.5%, respectively, in the conventional RFA group (<i>p</i> = 0.004, log-rank). In as-treated analysis using multivariable Cox regression analysis, RFA type was the only significant predictive factor for LTP (hazard ratio = 0.061 with conventional RFA as the reference, 95% confidence interval = 0.000-0.497; <i>p</i> = 0.004). There were no significant differences in the procedure characteristics between the two groups. No procedure-related deaths or major complications were observed.<h4>Conclusion</h4>NT-RFA using TICW electrodes in bipolar mode demonstrated significantly lower cumulative LTP rates than conventional RFA for small HCCs, which warrants a larger study for further confirmation.
Project description:Background: The prognosis of patients with hepatocellular carcinoma (HCC) is of major public health interest. However, studies comparing hepatic resection (HR) and radio-frequency ablation (RFA) applied to multifocal HCC are limited. This study aimed to compare the efficacies of HR and RFA in patients with multifocal HCC. Methods: We retrospectively analyzed a cohort from the Surveillance, Epidemiology, and End Results database between 2004 and 2015. Disease-specific survival and overall survival rates were assessed before and after propensity score matching (PSM). Results: In total, 2,201 patients with multifocal HCC treated with HR (n = 1,095) or RFA (n = 1,106) were included; 1,096 patients were identified after nearest-neighbor PSM at a ratio of 1:1 (HR: n = 548; RFA: n = 548). In the multivariate Cox regression model, HR was associated with significantly improved disease-specific survival [before PSM: hazard ratio 0.67, 95% confidence interval (CI) 0.57-0.79, p < 0.001; after PSM: hazard ratio 0.69, 95% CI 0.58-0.82, p < 0.001] and overall survival (before PSM: hazard ratio 0.67, 95% CI 0.58-0.78, p < 0.001; after PSM: hazard ratio 0.69, 95% CI 0.59-0.80, p < 0.001) compared to RFA in patients with multifocal HCC. In the survival curve analysis, the disease-specific survival of the HR group was similar to that of the RFA group before PSM (p = 0.936, log-rank test) but was significantly longer after PSM (p < 0.001) in all patients. Multivariate analyses revealed that differentiation grade, alpha-fetoprotein, tumor size, and tumor extension were independent predictors of poor prognosis in patients with multifocal HCC. Conclusions: The long-term survival rate of HR is better than that of RFA in patients with multifocal HCC. HR may serve as a first-line treatment for patients with multifocal HCC. The presence of large tumors and vascular invasion are not contraindications for HR.
Project description:The aim of our study was to compare early and long-term outcome of patients undergoing either on-pump or off-pump coronary artery bypass grafting with special focus on impairment of renal function. Five hundred ninety-three consecutive patients undergoing coronary artery bypass grafting were retrospectively analyzed. They were assigned either to on-pump (n = 281) or to off-pump (n = 312) group. Early and long-term outcomes were analyzed with special focus on renal function. Basic demographics and preoperative characteristics did not differ between groups (p>0.05) as well as postoperative renal parameters (p>0.05). Postoperative odds ratios (OR) of off-pump group in comparison to on-pump group were higher without reaching significance in terms of incidence of gastrointestinal complications and pneumonia (OR = 2.23 and 1.61, respectively) as well as hazard ratios (HR) on long-term follow-up for mortality and incidence of myocardial infarction (HR = 1.50 and 2.29, respectively). Kaplan-Meier estimation analysis also revealed similar results for both groups in terms of mid- and long-term survival (Breslow p = 0.062 and Log-Rank p = 0.064, respectively) and for incidence of myocardial infarction (Breslow p = 0.102 and Log-Rank p = 0.103, respectively). Our study suggests that use or not use of coronary artery bypass did not influence postoperative renal function. Odds of early outcomes were similar in both groups as well as incidence of myocardial infarction and mortality in long-term follow-up.
Project description:Background and Aims: Despite resection being considered the treatment of choice for intrahepatic cholangiocarcinoma (ICC), percutaneous thermal ablation can be an alternative treatment for patients unfit for surgery. Our aim was to compare long-term results of percutaneous sonographically-guided radiofrequency ablation (RFA) with high-powered microwave ablation (MWSA) in treatment of ICC. Methods: Results of 71 ICC patients with 98 nodules treated with RFA (36 patients) or MWSA (35 patients) between January 2008 and June 2018 in 5 Interventional Ultrasound centers of Southern Italy were retrospectively reviewed. Cumulative overall survival curves were calculated with the Kaplan-Meyer method and differences with the log-rank test. Eleven possible factors affecting survival were analyzed. Results: Overall survival of the entire series was 88%, 65%, 45% and 34% at 12, 36, 60 and 80 months, respectively. Patients treated with MWSA survived longer than patients treated with RFA (p < 0.005). The MWSA group with ICC nodules ?3 cm or nodules up to 4 cm survived longer than the RFA group (p < 0.0005). In patients with nodules >4 cm, no significant difference was found. Disease-free survival and progression-free survival were better in the MWSA group compared to the RFA group (p < 0.005). Diameter of nodules and MWSA were independent factors predicting a better survival. No major complications were observed. Conclusions: MWSA is superior to RFA in treating ICC unfit for surgery, achieving better long-term survival in small (?3 cm) ICC nodules as well as nodules up to 4 cm of neoplastic tumors and should replace RFA.
Project description:We performed a meta-analysis to evaluate the therapeutic effects of radiofrequency ablation (RFA) and surgical hepatic resection (HR) in the treatment of small hepatocellular carcinoma (HCC). Thirty-one studies were included in the analysis. A total of 16,103 patients were involved: 8,252 treated with RFA and 7,851 with HR. Compared to the RFA group, the 3, 5-year overall and disease-free survival rates in the HR group were significantly higher. On the other hand, complications were significantly fewer and hospital-stay was significantly shorter in the RFA group than in the HR group. In subgroup analyses, the overall and disease-free survival in the HR group were also significantly higher than those in the RFA group for HCCs ≤ 3 cm, whereas there were no significant differences between the two groups for HCCs ≤ 2 cm. Our analysis showed that although HR was associated with higher complication rate and longer hospital-stay, HR is proposed as the first-line treatment rather than RFA for patients with HCCs larger than 2 cm. For patients with HCCs of 2 cm or less, RFA may be an alternative to HR because of their comparable long-term efficacy.
Project description:Background: Percutaneous radiofrequency ablation (RFA) is one of the main treatments of small hepatocellular carcinoma (HCC). However, it remains unclear whether this local treatment can induce systemic immune variations. Methods: We conducted a prospective study in a tertiary center including consecutive cirrhotic patients with unifocal HCC<5 cm treated by a first RFA between 2010 and 2014. Peripheral blood mononuclear cells were isolated on the day before (D0), day after (D1) and month after RFA (M1). Frequencies and phenotypes of myeloid cells, T cells, and NK cells were compared between timepoints. Overall recurrence and associated variables were estimated using Kaplan-Meier, log-rank and Cox proportional-hazards models. Results: 80 patients were included (69% male, median age: 67 years old). Main aetiologies of HCC were alcohol (51%), hepatitis C virus (45%), non-alcoholic steatohepatitis (36%) and hepatitis B virus (9%). Median overall survival was 55 months (M); median progression-free survival was 29.5M. Among innate immune populations, we observed variations between D0, D1 and M1 in NKp30+ NK cells (p < .0001) and in plasmacytoid dendritic cells (pDC, p < .01). Concerning adaptive immunity, we observed variations in CD8 Central Memory (p < .05) and CD28+ CD8 Central Memory (p < .01). An early dynamic (D0/D1) of activated NKp30+ NK cells was associated with a decreased overall recurrence (log-rank, p = .016, median delay 25.1 vs 40.6 months). In contrast, a late dynamic (D1/M1) of immature NK cells (CD56bright) and altered myeloid DC (PDL1+) was associated with an increased overall recurrence (log-rank, p = .011 and p = .0044, respectively). In multivariate analysis, variation of immature NK cells predicts tumor recurrence independently of classical clinical prognostic features (HR = 2.41, 95% CI: 1.15-5.057), p = .019). Conclusions: Percutaneous RFA of small HCC leads to systemic modifications of innate and adaptive immunity closely linked with overall tumor recurrence.
Project description:Hepatocellular carcinoma has been considered to disseminate through the tumor blood drainage area. To improve curation rates, treatment should cover this area as it may contain satellite lesions. This retrospective study aimed to investigate whether radiofrequency ablation (RFA) completely covering the blood drainage area can improve the overall and disease-free survival. We enrolled 526 patients who underwent computed tomography during hepatic arteriography following RFA from April 2001 to May 2019. Patients were categorized into a covered group in which the blood drainage area was completely covered by RFA and a noncovered group in which coverage was incomplete. The primary endpoint was the overall survival rate; secondary outcomes included disease-free survival rate, distant intrahepatic and local recurrence rate, and changes in the Child-Pugh score. There were no significant differences in baseline characteristics between the two groups. Cumulative overall survival rates were significantly higher in the covered group than in the noncovered group (hazard ratio, 0.63; 95% confidence interval, 0.48-0.84; <i>P</i> = 0.002). On multivariate Cox proportional hazard model analysis, age <65 years, Child-Pugh class A, and coverage of the entire drainage area were independent protective factors. Child-Pugh worsened in 11 (4.2%) patients in the covered group compared to 18 (6.7%) patients in the noncovered group. <i>Conclusion:</i> RFA covering the complete drainage area improved overall survival without decreasing liver function.
Project description:Background:Sorafenib has been recommended as the first-line treatment and shown to prolong the median overall survival (OS) of patients with advanced unresectable hepatocellular carcinoma (HCC). Recently, a growing number of earlier studies showed the application of radiofrequency ablation (RFA) plus sorafenib in patients diagnosed at the advanced-stage HCC. This study aimed to compare the outcomes of RFA plus sorafenib versus sorafenib alone and identify prognostic factors related to OS for BCLC stage C patients with PS 1 but without vascular invasion or extrahepatic spread. Methods:A total of 276 consecutive patients in BCLC stage C with PS 1 but without vascular invasion or extrahepatic spread were enrolled in this retrospective study. Survival analyses were performed using the Kaplan-Meier analysis, and the log-rank test examined the statistical differences between the transarterial chemoembolization (TACE) and sorafenib groups. Univariate and multivariate Cox regression analyses were performed to investigate the prognostic factors for OS. Results:Based on the Kaplan-Meier curves, patients treated with RFA plus sorafenib showed better OS than those undergoing sorafenib, with respective OS at 1, 3 and 5 years (84.0%, 43.1%, 22.8% vs. 55.6%, 29.6%, 4.8%, Log-rank P<0.001). The univariate analysis and multivariate analysis showed that tumor size, tumor number, treatment method, albumin, bilirubin, and the Child-Pugh score were associated with OS. According to the subgroups analyses based on the tumor size and tumor number, there were significant differences in OS among overall subsets except in patients with tumor number ?4 between RFA plus sorafenib and sorafenib therapy. Conclusions:RFA plus sorafenib provided better prognostic performance than sorafenib, which should be suggested as an alternative treatment modality compared with sorafenib for BCLC stage C patients with PS 1 but without vascular invasion or extrahepatic spread.
Project description:OBJECTIVES: To evaluate the efficacy and safety of radiofrequency ablation (RFA) versus hepatic resection (HR) for early hepatocellular carcinoma (HCC) meeting the Milan criteria. METHODS: A meta-analysis was conducted, and PubMed, Web of Science, the Cochrane Library, CBM, CNKI and VIP databases were systematically searched through November 2012 for randomized and nonrandomized controlled trials (RCTs and NRCTs). The Cochrane Collaboration's tool and modified MINORS score were applied to assess the quality of RCTs and NRCTs, respectively. The GRADE approach was employed to evaluate the strength of evidence. RESULTS: Three RCTs and twenty-five NRCTs were included. Among 11,873 patients involved, 6,094 patients were treated with RFA, and 5,779 with HR. The pooled results of RCTs demonstrated no significant difference between groups for 1- and 3-year overall survival (OS), recurrence-free survival (RFS) and disease-free survival (DFS) (p>0.05). The 5-year OS (Relative Risk, RR 0.72, 95% CI 0.60 to 0.88) and RFS (RR 0.56, 95% CI 0.40 to 0.78) were lower with RFA than with HR. The 3- and 5-year recurrences with RFA were higher than with HR (RR 1.48, 95% CI 1.14 to 1.94, and RR 1.52, 95% CI 1.18 to 1.97, respectively), but 1-year recurrence and in-hospital mortality showed no significant differences between groups (p>0.05). The complication rate (RR 0.18, 95% CI 0.06 to 0.53) was lower and hospital stays (Mean difference -8.77, 95% CI -10.36 to -7.18) were shorter with RFA than with HR. The pooled results of NRCTs showed that the RFA group had lower 1-, 3- and 5-year OS, RFS and DFS, and higher recurrence than the HR group (p<0.05). But for patients with very early stage HCC, RFA was comparable to HR for OS and recurrence. CONCLUSION: The effectiveness of RFA is comparable to HR, with fewer complications but higher recurrence, especially for very early HCC patients.