NCT02534961

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_4 hepatocellular-carcinoma

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 28, 2015

Status Verified

August 1, 2015

Enrollment Period

2.9 years

First QC Date

August 25, 2015

Last Update Submit

August 25, 2015

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaRadiofrequency ablationAntibiotics

Outcome Measures

Primary Outcomes (1)

  • Infection 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.

    within 4 weeks after radiofrequency ablation

Study Arms (2)

prophylactic antibiotics group

ACTIVE COMPARATOR

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

on-demand antibiotics group

NO INTERVENTION

Patients in the on-demand group will receive antibiotic therapy only when infection will be suspected or established.

Interventions

CefazolinDRUG

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.

prophylactic antibiotics group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Chien-Wei Su, MD & PhD

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Wei Su, MD & PhD

CONTACT

886228712121cwsu2@vghtpe.gov.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2015

First Posted

August 28, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 28, 2015

Record last verified: 2015-08

Locations

TW(1)