Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma

Antibiotic Prophylaxis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654896
• Other study ID #: PKLI-IRB/AP/89
• Status: Recruiting
• Phase: Phase 3
• Start date: November 26, 2022
• Est. completion date: December 26, 2023

Study information

• Verified date: December 2022
• Source: Pakistan Kidney and Liver Institute and Research Center
• Contact: Ahmad Zia Ud Din, MBBS, FRCR
• Phone: +923028099040
• Email: ahmad.zia[@]pkli.org.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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'.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: December 26, 2023
• Est. primary completion date: November 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Prophylaxis
• Carcinoma, Hepatocellular

Intervention

Drug:
• Ceftriaxone Sodium
Antibiotic will be administered prophylactically for TACE

Locations

Country	Name	City	State
Pakistan	Pakistan Kidney and Liver Institute	Lahore	Punjab

Sponsors (3)

Lead Sponsor	Collaborator
Nadeem Iqbal	Ahmad Zia, Muhammad Junaid Tahir

Country where clinical trial is conducted

Pakistan, 

Outcome

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