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

Primary Purpose

Hepatocellular Carcinoma, Postoperative Infection

Status
Suspended
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
postoperative antimicrobial prophylaxis
No postoperative antimicrobial prophylaxis
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Postoperative antimicrobial prophylaxis

No postoperative antimicrobial prophylaxis

Arm Description

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

Patients will receive no antibiotics after hepatectomy, unless the clinicians suggest he/she need antibiotics to treat or prevent infection.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Surgical site infection rate
the incidence rate of surgical site infection, including infections of the incision or organ or space that occur after surgery.
Postoperative complication rate
the incidence rate of postoperative complications, grading as Clavien-Dindo grades
Severe infection rate
the incidence rate of postoperative complications over grade 3
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.

Full Information

First Posted
June 18, 2019
Last Updated
March 23, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03990974
Brief Title
Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in HCC After Liver Resection
Acronym
HCC
Official Title
Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in Hepatocellular Carcinoma After Liver Resection: A Multi-center, Randomized, Open-labelled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Suspended
Why Stopped
There were difficulties in implementation
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Postoperative Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
458 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Postoperative antimicrobial prophylaxis
Arm Type
Experimental
Arm Description
Patients will receive postoperative antimicrobial prophylaxis for 3 days in 24 hours after hepatectomy.
Arm Title
No postoperative antimicrobial prophylaxis
Arm Type
Sham Comparator
Arm Description
Patients will receive no antibiotics after hepatectomy, unless the clinicians suggest he/she need antibiotics to treat or prevent infection.
Intervention Type
Drug
Intervention Name(s)
postoperative antimicrobial prophylaxis
Intervention Description
The drugs are all common antibiotics used to prevent postoperative infection in each hospital.
Intervention Type
Other
Intervention Name(s)
No postoperative antimicrobial prophylaxis
Intervention Description
Patients will receive no antibiotics after hepatectomy unless necessary.
Primary Outcome Measure Information:
Title
30-day postoperative infection rate
Description
the incidence rate of postoperative infection occurred in 30 days after surgery, including surgical site infections, distant infection or infection from unknown sources
Time Frame
30 days after hepatectomy
Secondary Outcome Measure Information:
Title
Surgical site infection rate
Description
the incidence rate of surgical site infection, including infections of the incision or organ or space that occur after surgery.
Time Frame
30 days after hepatectomy
Title
Postoperative complication rate
Description
the incidence rate of postoperative complications, grading as Clavien-Dindo grades
Time Frame
3 months after hepatectomy
Title
Severe infection rate
Description
the incidence rate of postoperative complications over grade 3
Time Frame
30 days after hepatectomy
Title
Distant infection rate
Description
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.
Time Frame
30 days after hepatectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

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

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