Clinical Trial Of Laparoscopic Hepatectomy And Radiofrequency Ablation In The Treatment Of Small Hepatocellular Carcinoma

BackgroundThere is currently no clear consensus on the relative suitabilities of laparoscopic hepatectomy(LH)andradiofrequency ablation(RFA)as minimally-invasivetreatment for small hepatocellular carcinoma(HCC).This study was carried out for small HCC clinical trial is divided into two parts,the first part is a retrospective study,based on our Hepatobiliary Surgery Institute in 2007-2013 clinical data on patients with small HCC incidence were statistically analyzed and results preliminary conclusions.Articles published in surgical endoscopy and other interventional techniques,entitled Laparoscopic Hepatectomy vs Radiofrequency Ablation for Minimally Invasive Treatment of Single,Small Hepatocellular Carcinomas.The second part of small HCC were randomized controlled trials,the project is a single-center,prospective study after patients met the inclusion criteria signed informed consent to carry out treatment,patients enrolled for 1 year,after three years of follow-up draw final conclusions.This section has been approved by the PLA Third Military Medical University First Affiliated Hospital Ethics Committee,and the application for registration(Clinical Trails.gov Identifier: NCT02243384)in international clinical research official website.Currently,patients have completed the second part of the group,in this paper describes the experimental program and the current results,the next step will be followed up in accordance with the protocol and statistical analysis.MethodsThe first part: in this retrospective study,we enrolled 156 patients with a single small HCC with nodular diameters < 4 cm,and compared recurrence-free survival(RFS)and overall survival(OS)between patients treated with LH and control patients treated with RFA(n= 78 each).The groups were selected according to predefined criteria and matched in terms of their baseline clinical characteristics.The second part: a total of 150 patients met the solitary nodule diameter ≤ 5 cm or three nodules each having a diameter of not more than 3cm small HCC patients divided into LH group(n= 75)and RFA group(n= 75)conducted a randomized controlled trial.After treatment,regular follow-up of 3 years,the results of monitoring and evaluation period.ResultsThe first part: during a median follow-up of 31.2months,the 1-,2-,and 3-year OS rates in the LH group were 96.2%,91.3%,and 84.1%,respectively,compared with 96.2%,82.6%,and 78.8% in the RFA group.The corresponding RFS rates were 82.1%,71.5%,and 60.0% in the LH group and 65.4%,47.7%,and 37.6% in the RFA group.Combined RFS rates were significantly higher in the LH groups(P = 0.006),but there was no significant difference in OS rates(P = 0.510).The incidence of postoperative complications was significantly lower in the RFA group(28.2% vs.10.3%,P = 0.004),and operation duration,intraoperative blood loss and blood transfusion,use of total parenteral nutrition,and length of stay as indicators of minimal invasiveness were also significantly better in the RFA group.Multivariate analysis was used to identify independent risk factors associated with the recurrence: surgical approach(relative risk,RR: 1.957;95% CI: 1.245–3.077;P = 0.004)and tumor size(RR: 1.961;95% CI: 1.229–3.129;P = 0.005).It was also used to identify independent risk factors associated with survival: hepatitis B virus replication(RR: 0.352;95% CI: 0.160–0.775;P = 0.010).The second part: in 13 months,LH group and RFA group successfully completed the randomized groups.After a preliminary statistical analysis no significant differences in baseline characteristics between patients,tumor location and no difference.The incidence of complications LH group than in the RFA group more frequently(29/75 and 6/75,P < 0.05).Perioperative data RFA advantage still outstanding.Conclusions1.There was no difference between LH and RFA in terms of OS in patients with a single small HCC.However,RFA was less invasive than the LH,but LH was associated with increased RFS.2.This conclusion comes from the results of the first part of the study,to draw final conclusions need to follow-up after the completion of the second portion.