Hepatocellular Carcinoma, Postoperative Infection
Conditions
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.
Interventions
DRUGpostoperative antimicrobial prophylaxis
The drugs are all common antibiotics used to prevent postoperative infection in each hospital.
OTHERNo postoperative antimicrobial prophylaxis
Patients will receive no antibiotics after hepatectomy unless necessary.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complication rate | 3 months after hepatectomy | the incidence rate of postoperative complications, grading as Clavien-Dindo grades |
| Severe infection rate | 30 days after hepatectomy | the incidence rate of postoperative complications over grade 3 |
| 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. |
| 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. |
Countries
China
Outcome results
None listed