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出境医 / 临床实验 / Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in HCC After Liver Resection (HCC)

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

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Postoperative Infection Drug: postoperative antimicrobial prophylaxis Other: No postoperative antimicrobial prophylaxis Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in Hepatocellular Carcinoma After Liver Resection: A Multi-center, Randomized, Open-labelled Trial.
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. 30-day postoperative infection rate [ Time Frame: 30 days after hepatectomy ]
    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 :
  1. Surgical site infection rate [ Time Frame: 30 days after hepatectomy ]
    the incidence rate of surgical site infection, including infections of the incision or organ or space that occur after surgery.

  2. Postoperative complication rate [ Time Frame: 3 months after hepatectomy ]
    the incidence rate of postoperative complications, grading as Clavien-Dindo grades

  3. Severe infection rate [ Time Frame: 30 days after hepatectomy ]
    the incidence rate of postoperative complications over grade 3

  4. Distant infection rate [ Time Frame: 30 days after hepatectomy ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
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China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date March 25, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019) 		30-day postoperative infection rate [ Time Frame: 30 days after hepatectomy ]
the incidence rate of postoperative infection occurred in 30 days after surgery, including surgical site infections, distant infection or infection from unknown sources
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Surgical site infection rate [ Time Frame: 30 days after hepatectomy ]
    the incidence rate of surgical site infection, including infections of the incision or organ or space that occur after surgery.
  • Postoperative complication rate [ Time Frame: 3 months after hepatectomy ]
    the incidence rate of postoperative complications, grading as Clavien-Dindo grades
  • Severe infection rate [ Time Frame: 30 days after hepatectomy ]
    the incidence rate of postoperative complications over grade 3
  • Distant infection rate [ Time Frame: 30 days after hepatectomy ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in HCC After Liver Resection
Official Title  ICMJE Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in Hepatocellular Carcinoma After Liver Resection: A Multi-center, Randomized, Open-labelled Trial.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Hepatocellular Carcinoma
  • Postoperative Infection
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Postoperative antimicrobial prophylaxis
    Patients will receive postoperative antimicrobial prophylaxis for 3 days in 24 hours after hepatectomy.
    Intervention: Drug: postoperative antimicrobial prophylaxis
  • 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.
    Intervention: Other: No postoperative antimicrobial prophylaxis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: June 18, 2019) 		458
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03990974
Other Study ID Numbers  ICMJE 20190236
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ming Kuang, First Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Yat-sen University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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