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

NCT03990974 | Suspended Phase 3 DMC

• 1 other identifier: 20190236
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Postoperative Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Surgical site infection rate

  30 days after hepatectomy

• Postoperative complication rate

  3 months after hepatectomy

• Severe infection rate

  30 days after hepatectomy

• Distant infection rate

  30 days after hepatectomy

Study Arms (2)

Postoperative antimicrobial prophylaxis

EXPERIMENTAL

Patients will receive postoperative antimicrobial prophylaxis for 3 days in 24 hours after hepatectomy.

Drug: postoperative antimicrobial prophylaxis

No postoperative antimicrobial prophylaxis

SHAM COMPARATOR

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

Interventions

postoperative antimicrobial prophylaxis DRUG

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

Postoperative antimicrobial prophylaxis

No postoperative antimicrobial prophylaxis OTHER

Patients will receive no antibiotics after hepatectomy unless necessary.

No postoperative antimicrobial prophylaxis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 19, 2019
• Study Start: September 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

CN (1)