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

Phase 3

Suspended

• Conditions: Hepatocellular Carcinoma; Postoperative Infection
• Interventions: Drug: postoperative antimicrobial prophylaxis; Other: No postoperative antimicrobial prophylaxis

• Registration Number: NCT03990974
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25
• Study Start: 2020-09
• Primary Completion: 2021-06
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 458

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Postoperative antimicrobial prophylaxis	postoperative antimicrobial prophylaxis	Patients will receive postoperative antimicrobial prophylaxis for 3 days in 24 hours after hepatectomy.
No postoperative antimicrobial prophylaxis	No postoperative antimicrobial prophylaxis	Patients will receive no antibiotics after hepatectomy, unless the clinicians suggest he/she need antibiotics to treat or prevent infection.

Primary Outcome Measures

Name	Time	Method
30-day postoperative infection rate	30 days after hepatectomy	the incidence rate of postoperative infection occurred in 30 days after surgery, including surgical site infections, distant infection or infection from unknown sources

Secondary Outcome Measures

Name	Time	Method
Postoperative complication rate	3 months after hepatectomy	the incidence rate of postoperative complications, grading as Clavien-Dindo grades
Surgical site infection rate	30 days after hepatectomy	the incidence rate of surgical site infection, including infections of the incision or organ or space that occur after surgery.
Severe infection rate	30 days after hepatectomy	the incidence rate of postoperative complications over grade 3
Distant infection rate	30 days after hepatectomy	the incidence rate of distant infections, including respiratory system infection, urinary system infection, catheter related infections or sepsis (defined as fever (temperature ≥38 ℃) or elevated white blood cell (\> 10 x10\^9 / L) accompanied by sputum, urine, catheter secretions, or blood culture positive.

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China