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

NCT ID: NCT03990974

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE3
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2021-07-31

Brief 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.

Detailed 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.

Conditions

Hepatocellular Carcinoma; Postoperative Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Postoperative antimicrobial prophylaxis

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

Group Type: EXPERIMENTAL

postoperative antimicrobial prophylaxis

Intervention Type: DRUG

The drugs are all common antibiotics used to prevent postoperative infection in each hospital.

No postoperative antimicrobial prophylaxis

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

Group Type: SHAM_COMPARATOR

No postoperative antimicrobial prophylaxis

Intervention Type: OTHER

Patients will receive no antibiotics after hepatectomy unless necessary.

Interventions

postoperative antimicrobial prophylaxis

The drugs are all common antibiotics used to prevent postoperative infection in each hospital.

Intervention Type: DRUG

No postoperative antimicrobial prophylaxis

Patients will receive no antibiotics after hepatectomy unless necessary.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming Kuang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

20190236

Identifier Type: -

Identifier Source: org_study_id