Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma: an Open-label, Randomised, Prospective Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Leukocytosis
Study Overview
Brief Summary
This study aims to determine the effectiveness of prophylactic antibiotic use for TACE and occurrence of postoperative liver abscess.
There would be two comparison groups. Current standard of care treatment at PKLI&RC (as per local guidelines) would be given to all patients receiving TACE for the intervention group or 'antibiotic group' (i.e., Inj. Ceftriaxone 1g, intravenous × stat). While no antibiotic would be given to the 'no antibiotic group'.
Detailed Description
Liver cancer especially hepatocellular carcinoma (HCC) is among the top five most common carcinomas in the world. According to the latest Cardiovascular and Interventional Radiological Society of Europe (CIRSE) standards of practice guidelines (2021), routine antibiotic prophylaxis is not recommended. However, prophylactic antibiotics are recommended in cases where there is a high risk of developing a liver abscess. These include biliary obstruction or the presence of a bilioenteric anastomosis. This study aims to determine the effectiveness of prophylactic antibiotic use for TACE and occurrence of postoperative liver abscess.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of primary liver cancer or hepatocellular carcinoma.
- •Patients receiving TACE in PKLI & RC.
- •Patients giving informed consent.
Exclusion Criteria
- •Receiving two or more TACE during the same hospitalization
- •Use of any antibiotics other than the prophylactic antibiotic in 48hours prior to TACE
- •Known hypersensitivity to specified antibiotic used in the study
- •Incomplete or missing laboratory investigations and data
- •Taking Sorafenib before TACE
- •TACE combined with ablation or immunetherapy
- •Tumor size >10 cm
- •Portal vein thrombosis
- •Dilated biliary channels on CT scan / Billiary invasion by tumor
Arms & Interventions
Antibiotic Prophylaxis Group
Antibiotic will be administered prophylactically (i.e., Inj. Ceftriaxone 1g, intravenous × stat)
Intervention: Ceftriaxone Sodium (Drug)
Outcomes
Primary Outcomes
Leukocytosis
Time Frame: 2 days
Predominantly neutrophilic leukocytosis ( \> 11 ×109/L) with fever ( \> 38 °C) in upto 48 hours post-TACE
Liver abscess
Time Frame: 30 days
Occurrence of liver abscess as diagnosed by imaging within 30 days of the procedure
Liver abscess and intervention
Time Frame: 30 days
Liver abscess requiring an intervention (e.g., percutaneous transhepatic abscess drainage (PTAD), percutaneous transhepatic abscess puncture or liver abscess incision) within 30 days of TACE
Secondary Outcomes
No secondary outcomes reported
Investigators
Nadeem Iqbal
PakistanKidney
Pakistan Kidney and Liver Institute and Research Center