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

Sun Yat-sen University458 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

458

Conditions

Hepatocellular Carcinoma Postoperative Infection

Interventions

postoperative antimicrobial prophylaxisDRUG

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

No postoperative antimicrobial prophylaxisOTHER

Patients will receive no antibiotics after hepatectomy unless necessary.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

30-day postoperative infection rate

the incidence rate of postoperative infection occurred in 30 days after surgery, including surgical site infections, distant infection or infection from unknown sources

Time frame: 30 days after hepatectomy

Secondary Outcomes

Surgical site infection rate

the incidence rate of surgical site infection, including infections of the incision or organ or space that occur after surgery.

Time frame: 30 days after hepatectomy

Postoperative complication rate

the incidence rate of postoperative complications, grading as Clavien-Dindo grades

Time frame: 3 months after hepatectomy

Severe infection rate

the incidence rate of postoperative complications over grade 3

Time frame: 30 days after hepatectomy

Distant infection rate

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.

Time frame: 30 days after hepatectomy

Data from ClinicalTrials.gov

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