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

• Status: Suspended
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents

Criteria

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.