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Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma

NCT ID: NCT05654896

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-26

Study Completion Date

2023-12-26

Brief Summary

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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

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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.

Conditions

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Antibiotic Prophylaxis

Keywords

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Antibiotic TACE HCC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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No Antibiotic Prophylaxis Group

No antibiotic will be administered prophylactically for TACE.

Group Type NO_INTERVENTION

No interventions assigned to this group

Antibiotic Prophylaxis Group

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

Group Type EXPERIMENTAL

Ceftriaxone Sodium

Intervention Type DRUG

Antibiotic will be administered prophylactically for TACE

Interventions

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Ceftriaxone Sodium

Antibiotic will be administered prophylactically for TACE

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahmad Zia

UNKNOWN

Sponsor Role collaborator

Muhammad Junaid Tahir

UNKNOWN

Sponsor Role collaborator

Nadeem Iqbal

OTHER

Sponsor Role lead

Responsible Party

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Nadeem Iqbal

PakistanKidney

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmad Zia Ud Din

Role: PRINCIPAL_INVESTIGATOR

PKLI & RC, Lahore

Locations

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Pakistan Kidney and Liver Institute

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Ahmad Zia Ud Din, MBBS, FRCR

Role: CONTACT

Phone: +923028099040

Email: [email protected]

Muhammad Junaid Tahir, MBBS, BSC

Role: CONTACT

Email: [email protected]

Facility Contacts

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Nadeem Iqbal, FCPS*

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PKLI-IRB/AP/89

Identifier Type: -

Identifier Source: org_study_id