| IntroductionHepatocellular carcinoma(HCC) is one of the common malignant tumors, the incidence ranked fifth and the third most common cause of cancer-related death. China is one of the high incidence areas, the incidence is 30.3/100,000, about 14 million people died for HCC yearly, the mortality is 20.4/100,000. China accounts for 18.8% of all cancer related death and more than 50% of world’s HCC patients, which threats to people’s health and life seriously.HCC can be classified micro, small, large and huge HCC by the diameter of tumor. The surgery resection is main treatment for HCC, the surgical methods include laparoscopic hepatectomy(LH) and open hepatectomy(OH) at present, LH provides a new therapeutic approach for HCC patients. In 1993, Wayand reported LH treatment of metastatic liver cancer at first; In 1995, Hashizume reported the first HCC case treated by laparoscope successly in the world. Through 20 years development, the effective of LH for HCC has been acknowledged, the indication expanded, and the cases growth exponentially in literatures for LH treatment of HCC.Tumor size and location are two key factors for LH treatment of HCC successly. For the tumor location, the previous literatures and our research results show that LH for the treatment of some patients with HCC in posterosuperior liver segments is safe and feasible while compared with HCC in anterolateral liver segments and the traditional laparotomy, which suggests that LH can be applied to all liver segments, HCC in posterosuperior liver segments is no longer a contraindicated for LH. But for the tumor size, which has been controverting especially for the large HCC.In 2008, the Louisville Statement suggested the indications for LH are solitary lesion and 5 cm or less in tumor size, this statement has been widely accepted at present.The tumor size > 10 cm was widely regarded as contraindications for LH at the present, considering the difficultion of operation and R0 resection.However, the safety and feasibility of LH for larger HCC is still not clear. Only a few retrospective literatures showed that LH for some large HCC patients was safe and feasible, and the level of the evidence-based medicine is low, there is no prospective study demonstrates the safety and feasibility of LH for large HCC.ObjectiveThe perioperative and postoperative follow-up results were compared and analyzed between the LH and the OH group for large HCC, which through prospective chort study. Aims to demonstrate the safety and feasibility of LH for large HCC and provide a higher level of evidence-based medical evidence for LH treatment of large HCC cases.Methods and resultsLarge HCC patients, all who fit the inclusion criteria, were selected from the Southwest Hospital of the Third Military Medical University from January 2012 to January 2015. The patients were divided into two groups according to the operation methods: the laparoscopic hepatectomy group(LH group) which the operation was carried in unit E and the open hepatectomy group(OH group) which the operation was carried in unit A and D. This study has been approval by the Ethics Committee of the Southwest Hospital of the Third Military Medical University and registered in the international clinical research’s site.Postoperative assessment of the outcomes was conducted by follow-ups through telephone calls and clinical visits at the Clinical Research Center of Hepatobiliary Surgery, Southwest Hospital of the Third Military Medical University. Re-examination involved liver function testing, AFP measurement, and abdominal ultrasound examination. Patients with suspected recurrence underwent enhanced CT scanning of the upper abdomen, ultrasound contrast examination or MRI for clarity. Those diagnosised patients were treated by a second laparoscopy or laparotomic hepatectomy, RFA, TACE, and liver transplantation according to the size, site, and number of lesions. Re-examination was performed once every 3 months in the first postoperative year, once every 4 months in the second postoperative year, and once every 6 months after the third postoperative year.To evaluate the safety and feasibility of LH for the treatment of large HCC, two groups of patients with perioperative, tumor recurrence and survival data were collected and analyzed.Data were analyzed using SPSS 19.0 statistical software(IBM SPSS, Somers, NY, USA). Measurement data were described as mean ± standard deviation and subjected to the t-test or the Wilcoxon rank-sum test. Count data were analyzed using the χ2 or Fisher’s exact test. Survival curves were plotted using the Kaplan–Meier method. Patient survival was compared between the two groups using the log-rank test. The P value of <0.05 was considered statistically significant.The two groups of patients were compared in terms of the following parameters:(1) general information(sex, age, hepatitis B surface antigen, alpha fetoprotein(AFP), Child-Pugh classification of liver function, ICG-15 R,cirrhosis, SLV/RFLV and preoperative liver function),(2) intraoperative parameters(operation time, blood loss, transfusion rate, conversion rate from laparoscopy to laparotomy, lesion diameter, resection margin of the specimens, surgical approach,the propartion of first hepatic portal inflow occlusion, and inflow occlusion time)(3) postoperative parameters(SICU time, time for dieting, time for removal of the abdominal cavity drainage tube,postoperative anal exhaust time, postoperative complication rate, mortality, postoperative hospital stay, and liver function recovery).Perioperative resultsLH group and OH group after operation had 1 and 2 cases death respectively for serious complications. A patient died for liver failure in week after operation in LH group. A patient died two weeks after operation, who suffered hepatic dysfunction and secondary to a large amount of ascites, which infected by staphylococcus haemolyticus and leaded to multiple organ failure. In addition, a patient occurred pulmonary infection seriously, respiratory failure and blood multidrug-resistant acinetobacter baumannii infections, but the antibiotics treatment ineffectively. The rest of complications including liver section encapsulated fluid, bile leakage, ascites, pulmonary infection and heart failure, the patients discharged through actively treatment. The postoperative complication rate(21.1% vs 36.2%;P=0.005),was statistically significant different between the two groups.There were no statistically significant differences between the two groups of patients in the operation time(234.4± 66.7 vs235.5±62.6min;P=0.886), blood loss(458.9±338.6 vs481.3±384.5ml;P=0.589), blood transfusion rate(18.0% vs 20.3%, P =0.602) and tumor size(6.7±1.5 vs 6.9±1.5㎝;P=0.331), the resection margin(1.5±0.5 vs 1.5±0.6㎝;P=0.212), proportion of first hepatic portal inflow occlusion(41.4% vs 41.5%;P=0.980)and inflow occlusion time(41.3 ± 16.3 vs 31.3 ± 12.2 min, P = 0.005).Proportion of anatomic hepatectomy(45.3% vs 21.7%; P =0.000) was significantly different between the two groups, the proportion of anatomic hepatectomy in LH group is higher than OH group.LH group has 12 patients conversion to laparotomy, 2 cases of hepatic vein injury, 1 cases of right hepatic vein injury, 5 case of liver parenchyma deep hemorrhage, 1 cases of right adrenal venous injury, 3 cases of resection margin positive, the conversion rate was 9.3%(12/128). The SICU time(1.4±0.5 vs 2.0±0.7days;P=0.000), time for dieting(2.4±0.5 vs 2.9±0.7 days;P=0.000), time for removal of the abdominal cavity drainage tube( 4.9±1.1 vs 6.1±1.0 days;P=0.000),postoperative anal exhaust time(3.1±±0.6 vs 4.1±0.6 days;P=0.000) and postoperative hospital stay(11.4±3.1vs 15.8±7.7 days;P=.000) and the serum ALT, AST,TB,DB and Alb levels on postoperative days 1,3,5 and 7 were statistically significant differences between the two groups.Follow-up resultsAfter 1 to 40 months of follow-up, the median follow-up time was 18.5 months. In LH group, 7 patients lost to follow-up, and the follow-up rate was 94.5%, 25 patients died because of tumor recurrence; 42 patients with tumor recurrence, in which 16 patients underwent RFA, 4 patients underwent LH again, 7 patients underwent OH, 8 patients underwent TACE, 2 patients underwent liver transplantation; 5 patients gave up treatment for multiple liver metastases, peritoneal cancer or lung metastasis. In OH group, 13 patients lost to follow-up, and the follow-up rate was 93.7%; 38 patients died because of tumor recurrence; 82 patients with tumor recurrence, in which 40 patients underwent RFA, 14 patients underwent OH, 18 patients underwent TACE, 2 patients underwent liver transplantation, 8 patients gave up treatment for multiple liver metastases, peritoneal cancer or lung metastasis.The follow-up rate(94.5% vs 93.7%) was no statistically significant differences in two groups.The 1- and 3-year overall survival rates of the LH and OH groups were 94% vs 93% and 81% vs 82%, respectively, with no statistically significant differences between the groups. The corresponding 1-and 3-year disease-free survival rates were 89% vs 88% and 67% vs 66%, respectively, with no statistically significant differences.Conclusions1.LH is safe and feasible for some patients with large HCC,the postoperative anal exhaust time, length of hospital stay and postoperative complications rate are superior to laparotomy, and the resection margin,1,3 overall and disease-free survival rates are comparable with laparotomy.2. This study confirmed that LH is safe and feasible for some large HCC patients by a prospective cohort study for the first time, and provides a higher level of evidence-based medical evidence for treatment of large HCC by laparoscopy. |
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