Prophylactic Antibiotics Before RFA for HCC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Cefazolin||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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.
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
|Contact: Chien-Wei Su, MD & PhD||886228712121 ext email@example.com|
|Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital||Recruiting|
|Taipei, Taiwan, 112|
|Contact: Chien-Wei Su, MD & PhD 886228712121 ext 3352 firstname.lastname@example.org|
|Principal Investigator:||Chien-Wei Su, MD & PhD||Taipei Veterans General Hospital, Taiwan|