Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma

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

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'.

Study Overview

• Status: Recruiting
• Conditions: Antibiotic Prophylaxis
• Intervention / Treatment: Drug: Ceftriaxone Sodium

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 Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ahmad Zia Ud Din, MBBS, FRCR; Phone Number: +923028099040; Email: ahmad.zia@pkli.org.pk
• Study Contact Backup: Name: Muhammad Junaid Tahir, MBBS, BSC; Email: junaid262626@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Recruiting
      • Pakistan Kidney and Liver Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: No Antibiotic Prophylaxis Group; No antibiotic will be administered prophylactically for TACE.
EXPERIMENTAL: Antibiotic Prophylaxis Group; Antibiotic will be administered prophylactically (i.e., Inj. Ceftriaxone 1g, intravenous × stat)	Drug: Ceftriaxone Sodium; Antibiotic will be administered prophylactically for TACE

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nadeem Iqbal
• Collaborators: Ahmad Zia; Muhammad Junaid Tahir
• Investigators: Principal Investigator: Ahmad Zia Ud Din, PKLI & RC, Lahore

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 26, 2022
• Primary Completion (ANTICIPATED): November 26, 2023
• Study Completion (ANTICIPATED): December 26, 2023

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (ACTUAL): December 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: HCC; Antibiotic; TACE
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular; Anti-Infective Agents; Anti-Bacterial Agents; Ceftriaxone
• Other Study ID Numbers: PKLI-IRB/AP/89

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No