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

Sun Yat-sen University

Status and phase: Suspended; Phase 3

Conditions: Hepatocellular Carcinoma; Postoperative Infection

Treatments: Other: No postoperative antimicrobial prophylaxis; Drug: postoperative antimicrobial prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT03990974

20190236

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 458 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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458 participants in 2 patient groups

Postoperative antimicrobial prophylaxis

Experimental group

Description:

Patients will receive postoperative antimicrobial prophylaxis for 3 days in 24 hours after hepatectomy.

Treatment:

Drug: postoperative antimicrobial prophylaxis

No postoperative antimicrobial prophylaxis

Sham Comparator group

Description:

Patients will receive no antibiotics after hepatectomy, unless the clinicians suggest he/she need antibiotics to treat or prevent infection.

Treatment:

Other: No postoperative antimicrobial prophylaxis