Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in HCC After Liver Resection

Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in Hepatocellular Carcinoma After Liver Resection: A Multi-center, Randomized, Open-labelled Trial.

This trial is a multi-center, double-blinded, randomized (1:1) clinical trial. The aim is to compare the postoperative infection rate between the 3 days postoperative AMP group and the placebo group in HCC patients undergoing hepatectomy.

This trial includes two phase. The first phase is the internal pilot study to explore the expulsion rate and recruited population. The second phase is the main phase III trial.

Inclusion Criteria:

• Age: over 18 years;
• Diagnosed as primary HCC according to the EASL criteria and plan to receive hepatectomy;
• Child-Pugh A class;
• No history of antibiotics in 1 week before surgery, except for antimicrobial prophylaxis in the 24h before surgery.
• No evidence of infection during preoperational assessment

Exclusion Criteria:

• Underwent hepatectomy combined with resection of other organs, except for gallbladder;
• Found obvious infection during operation;
• Combination with other operations, such as biliary reconstruction or tube drainage, bile duct exploration and stone remove, etc.;
• Allergic to the antibiotics used in the 24h before surgery;
• Emergency surgery;
• Tumor rupture;
• Did not underwent hepatectomy because of any reasons;
• Admission to ICU after surgery;
• ASA grade ≥ 3;
• Denial of informed consent.