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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in Hepatocellular Carcinoma After Liver Resection: A Multi-center, Randomized, Open-labelled Trial.

Conditions
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Hepatocellular Carcinoma, Postoperative Infection

Intervention / Treatment
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* Drug: postoperative antimicrobial prophylaxis
* Other: No postoperative antimicrobial prophylaxis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postoperative antimicrobial prophylaxis<br>Patients will receive postoperative antimicrobial prophylaxis for 3 days in 24 hours after hepatectomy. | Drug: postoperative antimicrobial prophylaxis<br>* The drugs are all common antibiotics used to prevent postoperative infection in each hospital.<br>|
| Sham Comparator: No postoperative antimicrobial prophylaxis<br>Patients will receive no antibiotics after hepatectomy, unless the clinicians suggest he/she need antibiotics to treat or prevent infection. | Other: No postoperative antimicrobial prophylaxis<br>* Patients will receive no antibiotics after hepatectomy unless necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days after hepatectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection rate | the incidence rate of surgical site infection, including infections of the incision or organ or space that occur after surgery. | 30 days after hepatectomy | 
| Postoperative complication rate | the incidence rate of postoperative complications, grading as Clavien-Dindo grades | 3 months after hepatectomy | 
| Severe infection rate | the incidence rate of postoperative complications over grade 3 | 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. | 30 days after hepatectomy |