Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05654896

Enrollment

158

Registered

2022-12-16

Start date

2022-11-26

Completion date

2023-12-26

Last updated

2022-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Prophylaxis

Keywords

Antibiotic, TACE, HCC

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.

Interventions

DRUGCeftriaxone Sodium

Antibiotic will be administered prophylactically for TACE

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Diagnosis of primary liver cancer or hepatocellular carcinoma. 2. Patients receiving TACE in PKLI & RC. 3. Patients giving informed consent.

Exclusion criteria

1. Receiving two or more TACE during the same hospitalization 2. Use of any antibiotics other than the prophylactic antibiotic in 48hours prior to TACE 3. Known hypersensitivity to specified antibiotic used in the study 4. Incomplete or missing laboratory investigations and data 5. Taking Sorafenib before TACE 6. TACE combined with ablation or immunetherapy 7. Tumor size \>10 cm 8. Portal vein thrombosis 9. Dilated biliary channels on CT scan / Billiary invasion by tumor

Design outcomes

Primary

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

Countries

Pakistan

Contacts

Primary ContactAhmad Zia Ud Din, MBBS, FRCR

ahmad.zia@pkli.org.pk+923028099040

Backup ContactMuhammad Junaid Tahir, MBBS, BSC

junaid262626@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026