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

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ClinicalTrials.gov Identifier: NCT03990974
Recruitment Status : Not yet recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ming Kuang, First Affiliated Hospital, Sun Yat-Sen University

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.

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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 : July 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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.




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990974


Contacts
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Contact: Ming Kuang, PhD. 008687755766 ext 8576 kuangm@mail.sysu.edu.cn

Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Ming Kuang, Professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03990974     History of Changes
Other Study ID Numbers: 20190236
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Carcinoma
Infection
Communicable Diseases
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases