Xiaobin et al. BMC Cancer 2012, 12:340 http://www.biomedcentral.com/1471-2407/12/340 without the Pringle maneuver reduces recurrence rate and improves disease-free survival rate. Trial population Our study group includes researchers in five leading hospitals in China (Southwest Hospital, Chinese PLA General Hospital, Zhongshan Hospital, Nanjing Drum Tower Hospital, and the First Affiliated Hospital of SunYet-Sen University) located in the southwestern, northern, eastern, middle, and southern parts of China, respectively. All eligible patients from these five partici- pating hospitals with a clinical diagnosis of HCC with infection will be enrolled. The study will include patients’ aged 18 years or older undergoing potentially curative (R0) resection, if preoperative imaging indicates that R0 resection can be undertaken both with and with- out the Pringle maneuver. Patients with extrahepatic dis- ease, severe liver cirrhosis, or tumor-positive lymph nodes in the abdomen or hepatoduodenal ligament will be excluded. We anticipate that 50 eligible cases per month will be enrolled in the trial. A detailed list of all eligibility criteria follows. Eligibility criteria 1. Aged from 18 to 65 years, no gender restriction. 2. Clinical diagnosis of resectable HCC. 3. Liver function tests showing Child-Pugh grade A and clearance of indocyanine green at 15 minutes (ICG-R15) less than 15%. 4. Tumor nodes in the liver which can be radically excised. 5. No preoperative anti-cancer therapy. 6. Written informed consent from the patient or legal guardian prior to enrollment in the study. Page 3 of 8 Exclusion criteria 1. Pregnancy. 2. Extrahepatic tumor or lymph node metastasis. 3. 3.Tumor invasion or thrombosis in the portal vein, hepatic vein, or inferior vena cava. 4. Surgical marginal positive. Study design This study is funded by the National Major Science and Technology Project of China on the prevention and treatment of infectious diseases, for human immunodefi- ciency virus and HBV [2008ZX10002-026]. This clinical trial is a registered [NCT00725335], prospective, intrao- peratively randomized multicenter trial of patients undergoing curative resection for HCC. The patients will be stratified by center and allocated to groups by a permuted-blocks randomization protocol. The primary objective of this study is to compare the disease free- survival rates at 1, 2, and 3 years postoperatively be- tween the two groups. We hypothesize that the long- term prognosis of patients who have undergone curative resection will be worse in the control group (Pringle maneuver) than in the experimental group (non-Pringle maneuver). The detailed study design is shown in Figure 1. Surgical interventions All surgical interventions in this trial are described in the study protocol. Incision lines and decision-making Specific teams of surgeons have been designated in each center participating in this trial, and have completed the Figure 1 Detailed flow chart of the clinical trial. Eligible patients from five centers will be enrolled, and randomly divided into an experimental group and a control group by permuted-blocks randomization. Each patient will be followed up for 3 years after their primary operation.