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Prophylactic Antibiotics Before RFA for HCC

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ClinicalTrials.gov Identifier: NCT02534961
Recruitment Status : Unknown
Verified August 2015 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
First Posted : August 28, 2015
Last Update Posted : August 28, 2015
Sponsor:
Collaborator:
Taipei Medical University Hospital
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
This randomized prospective study aims to investigate whether prophylactic administration of antibiotics has an influence on inflammatory markers, liver function test results, or the incidence of post-procedural infection in patients with hepatocellular carcinoma (HCC) undergoing radiofrequency ablation (RFA).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Cefazolin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylactic Administration of Antibiotics Before Radiofrequency Ablation for Hepatocellular Carcinoma: A Randomized Trial
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: prophylactic antibiotics group
Patients in the prophylactic group will receive antibiotic treatment right after randomization with intravenous cefazolin 2 g (3 g for patients weighing ≥120 kg) within 60 minutes before ablation therapy.
Drug: Cefazolin
Patients in the prophylactic group will receive antibiotic treatment right after randomization with intravenous cefazolin 2 g (3 g for patients weighing ≥120 kg) within 60 minutes before ablation therapy. Patients in the on-demand group will receive antibiotic therapy only when infection will be suspected or established. Antibiotics will be changed according to the antibiotic sensitivity test of cultured microorganisms.

No Intervention: on-demand antibiotics group
Patients in the on-demand group will receive antibiotic therapy only when infection will be suspected or established.



Primary Outcome Measures :
  1. Infection after radiofrequency ablation [ Time Frame: within 4 weeks after radiofrequency ablation ]
    Body temperature will be measured every 6 hour for 72 hour. Acetaminophen at 500 mg will be used when patients complain of pain or have a high grade fever over 39°C after the procedure. The numbers of peripheral blood leukocytes, as well as levels of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), creatinine, C-reactive protein (CRP) and infection signs as above descriptions will be determined before, and at 24 hour, 3-7 day and 4 week after ablation therapy.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with HCC and underwent RFA
  2. With tumor size less than 5 cm without extra-hepatic metastasis;

2. The number of tumor was 3 or less; 3. Child Pugh classification of liver function are grade A or B; 4. Absence of other major diseases that might complicate RFA.

Exclusion Criteria:

  1. Age is younger than 20 years or older than 80 years.
  2. Patients have a terminal illness of any major organ system, like heart failure, uremia, chronic obstructive pulmonary disease, or non-hepatic malignancy.
  3. Patients have received antibiotics within the last 2 weeks. Patients will be subsequently excluded when initial bacteriological sampling turned out positive (occult infection).

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): NCT02534961


Contacts
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Contact: Chien-Wei Su, MD & PhD 886228712121 ext 3352 cwsu2@vghtpe.gov.tw

Locations
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Taiwan
Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Chien-Wei Su, MD & PhD    886228712121 ext 3352    cwsu2@vghtpe.gov.tw   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Taipei Medical University Hospital
Investigators
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Principal Investigator: Chien-Wei Su, MD & PhD Taipei Veterans General Hospital, Taiwan

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT02534961     History of Changes
Other Study ID Numbers: 2015-01-003B
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Hepatocellular carcinoma
Radiofrequency ablation
Antibiotics

Additional relevant MeSH terms:
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Carcinoma
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
Anti-Bacterial Agents
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents