Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma

NCT05654896 | Unknown Phase 3

• 1 other identifier: PKLI-IRB/AP/89
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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'.

Conditions

Antibiotic Prophylaxis

Keywords

Antibiotic; TACE; HCC

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

No Antibiotic Prophylaxis Group

NO INTERVENTION

No antibiotic will be administered prophylactically for TACE.

Antibiotic Prophylaxis Group

EXPERIMENTAL

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

Drug: Ceftriaxone Sodium

Interventions

Ceftriaxone Sodium DRUG

Antibiotic will be administered prophylactically for TACE

Antibiotic Prophylaxis Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary liver cancer or hepatocellular carcinoma.
• Patients receiving TACE in PKLI \& RC.
• Patients giving informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Nadeem Iqbal: lead
• Ahmad Zia: collaborator
• Muhammad Junaid Tahir: collaborator

Study Sites (1)

Pakistan Kidney and Liver Institute

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Interventions

Ceftriaxone

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ahmad Zia Ud Din

  PKLI & RC, Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad Zia Ud Din, MBBS, FRCR

CONTACT

+923028099040; ahmad.zia@pkli.org.pk

Muhammad Junaid Tahir, MBBS, BSC

CONTACT

junaid262626@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PakistanKidney

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: November 26, 2022
• Primary Completion: November 26, 2023
• Study Completion: December 26, 2023
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)