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Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma

Primary Purpose

Antibiotic Prophylaxis

Status

Recruiting

Phase

Phase 3

Locations

Pakistan

Study Type

Interventional

Intervention

Ceftriaxone Sodium

About this trial

This is an interventional prevention trial for Antibiotic Prophylaxis focused on measuring Antibiotic, TACE, HCC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of primary liver cancer or hepatocellular carcinoma. Patients receiving TACE in PKLI & RC. Patients giving informed consent. Exclusion Criteria: 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

Sites / Locations

Pakistan Kidney and Liver InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Antibiotic Prophylaxis Group

Antibiotic Prophylaxis Group

Arm Description

No antibiotic will be administered prophylactically for TACE.

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

Outcomes

Primary Outcome Measures

Leukocytosis

Predominantly neutrophilic leukocytosis ( > 11 ×109/L) with fever ( > 38 °C) in upto 48 hours post-TACE

Liver abscess

Occurrence of liver abscess as diagnosed by imaging within 30 days of the procedure

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05654896

First Posted

December 8, 2022

Last Updated

December 8, 2022

Sponsor

Nadeem Iqbal

Collaborators

Ahmad Zia, Muhammad Junaid Tahir

1. Study Identification

Unique Protocol Identification Number

NCT05654896

Brief Title

Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 26, 2022 (Actual)

Primary Completion Date

November 26, 2023 (Anticipated)

Study Completion Date

December 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nadeem Iqbal

Collaborators

Ahmad Zia, Muhammad Junaid Tahir

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Antibiotic Prophylaxis

Keywords

Antibiotic, TACE, HCC

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

No Antibiotic Prophylaxis Group

Arm Type

No Intervention

Arm Description

No antibiotic will be administered prophylactically for TACE.

Arm Title

Antibiotic Prophylaxis Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ceftriaxone Sodium

Intervention Description

Antibiotic will be administered prophylactically for TACE

Primary Outcome Measure Information:

Title

Leukocytosis

Description

Predominantly neutrophilic leukocytosis ( > 11 ×109/L) with fever ( > 38 °C) in upto 48 hours post-TACE

Time Frame

2 days

Title

Liver abscess

Description

Occurrence of liver abscess as diagnosed by imaging within 30 days of the procedure

Time Frame

30 days

Title

Liver abscess and intervention

Description

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

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmad Zia Ud Din, MBBS, FRCR

Phone

+923028099040

ahmad.zia@pkli.org.pk

First Name & Middle Initial & Last Name or Official Title & Degree

Muhammad Junaid Tahir, MBBS, BSC

junaid262626@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmad Zia Ud Din

Organizational Affiliation

PKLI & RC, Lahore

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pakistan Kidney and Liver Institute

City

Lahore

State/Province

Punjab

ZIP/Postal Code

54000

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nadeem Iqbal, FCPS*

Phone

+92 3345346538

dr_nadeemiqbal84@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma

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