Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma

Nadeem Iqbal

Status and phase: Enrolling; Phase 3

Conditions: Antibiotic Prophylaxis

Treatments: Drug: Ceftriaxone Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT05654896

PKLI-IRB/AP/89

Details and patient eligibility

About

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'.

Full 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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

158 participants in 2 patient groups

No Antibiotic Prophylaxis Group

No Intervention group

Description:

No antibiotic will be administered prophylactically for TACE.

Antibiotic Prophylaxis Group

Experimental group

Description:

Antibiotic will be administered prophylactically (i.e., Inj. Ceftriaxone 1g, intravenous × stat)

Treatment:

Drug: Ceftriaxone Sodium