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

Hepatocellular Carcinoma Clinical Trial

— HCC  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03990974
• Other study ID #: 20190236
• Status: Suspended
• Phase: Phase 3
• Start date: September 2020
• Est. completion date: July 2021

Study information

• Verified date: March 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 458
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Communicable Diseases
• Hepatocellular Carcinoma
• Infection
• Postoperative Infection

Intervention

Drug:
• postoperative antimicrobial prophylaxis
The drugs are all common antibiotics used to prevent postoperative infection in each hospital.

Other:
• No postoperative antimicrobial prophylaxis
Patients will receive no antibiotics after hepatectomy unless necessary.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Postoperative complication rate	the incidence rate of postoperative complications, grading as Clavien-Dindo grades	3 months after hepatectomy
Secondary	Severe infection rate	the incidence rate of postoperative complications over grade 3	30 days after hepatectomy
Secondary	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