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

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

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.

Study Overview

• Status: Suspended
• Conditions: Hepatocellular Carcinoma; Postoperative Infection
• Intervention / Treatment: Drug: postoperative antimicrobial prophylaxis; Other: No postoperative antimicrobial prophylaxis

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 Type: Interventional
• Enrollment (Anticipated): 458
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Postoperative antimicrobial prophylaxis; Patients will receive postoperative antimicrobial prophylaxis for 3 days in 24 hours after hepatectomy.	Drug: postoperative antimicrobial prophylaxis; The drugs are all common antibiotics used to prevent postoperative infection in each hospital.
SHAM_COMPARATOR: No postoperative antimicrobial prophylaxis; 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; Patients will receive no antibiotics after hepatectomy unless necessary.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (ACTUAL): June 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Infections; Communicable Diseases; Carcinoma, Hepatocellular; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 20190236

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No