Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma: an Open-label, Randomised, Prospective Study

Conditions
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Antibiotic Prophylaxis

Intervention / Treatment
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* Drug: Ceftriaxone Sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Antibiotic Prophylaxis Group<br>No antibiotic will be administered prophylactically for TACE. | |
| Experimental: Antibiotic Prophylaxis Group<br>Antibiotic will be administered prophylactically (i.e., Inj. Ceftriaxone 1g, intravenous × stat) | Drug: Ceftriaxone Sodium<br>* Antibiotic will be administered prophylactically for TACE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocytosis | Predominantly neutrophilic leukocytosis ( > 11 ×109/L) with fever ( > 38 °C) in upto 48 hours post-TACE | 2 days | 
| Liver abscess | Occurrence of liver abscess as diagnosed by imaging within 30 days of the procedure | 30 days | 
| Liver abscess and intervention | 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 | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic, TACE, HCC