Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma

Phase 3

Recruiting

• Conditions: Antibiotic Prophylaxis
• Interventions: Drug: Ceftriaxone Sodium

• Registration Number: NCT05654896
• Lead Sponsor: Nadeem Iqbal

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 Timeline

• Study Start: 2022-11-26
• Status Verified: 2022-12
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-08
• Last Update Submitted: 2022-12-08
• Study First Posted: 2022-12-16
• Last Update Posted: 2022-12-16
• Primary Completion: 2023-11-26
• Study Completion: 2023-12-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic Prophylaxis Group	Ceftriaxone Sodium	Antibiotic will be administered prophylactically (i.e., Inj. Ceftriaxone 1g, intravenous × stat)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pakistan Kidney and Liver Institute; 🇵🇰 Lahore, Punjab, Pakistan