Introduction
Background and rationale
Objectives
Trial design
Methods
Study setting
Eligibility criteria
Recruitment
Who will take informed consent?
Additional consent provisions for collection and use of participant data and biological specimens
Interventions
Explanation of the choice of comparators
Description of interventions
Criteria for discontinuing or modifying allocated interventions
Strategies to improve adherence to interventions
Relevant concomitant care permitted or prohibited during the trial
Provisions for post-trial care
Outcomes
Assessment measures | Preoperation | Postoperative day 5 | One month after surgery | Two months after surgery | Three months after surgery | Six months after surgery | Every six months until HCC recurrence /metastasis or death |
---|---|---|---|---|---|---|---|
Blood routine examination | x | x | x | x | x | x | x |
Urine routines | x | x | x | x | x | x | x |
Stool routine examination | x | x | x | x | x | x | x |
Liver function | x | x | x | x | x | x | x |
Renal function | x | x | x | x | x | x | x |
Myocardial enzyme | x | x | x | x | x | x | x |
Hepatitis B virological test1 | x | x | x | x | x | x | |
Coagulation function | x | x | x | x | x | x | x |
Lipid level2 | x | x | x | x | x | x | |
Alpha fetoprotein | x | x | x | x | x | x | |
Des-gamma-carboxy prothrombin | x | x | x | x | x | x | |
Hepatits C antibody | x | ||||||
Human immunodeficiency virus antibody | x | ||||||
• Blood HCG test3 | x | ||||||
Electrocardiogram | x | x | x | x | x | x | |
Abdominal ultrasonography | x | x | x | x | x | x | |
Chest and upper abdomen enhanced MRI/CT | x | x | x | x | x | x |