Prophylactic Antibiotic Use in Transarterial Chemoemboliz... | NCT05654896

Studies
Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma

NCT05654896

Sponsor

Nadeem Iqbal

Status

Unknown status

Last Update Posted

Dec 16, 2022Actual

Enrollment

158Estimated

Phase

Phase 3

Conditions

Antibiotic Prophylaxis

Interventions

Ceftriaxone Sodium

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 26, 2022Actual

Primary Completion Date

Nov 26, 2023Estimated

Completion Date

Dec 26, 2023Estimated

First Submitted Date

Dec 8, 2022

First Submission Date that Met QC Criteria

Dec 8, 2022

First Posted Date

Dec 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2022

Last Update Posted Date

Dec 16, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nadeem Iqbal, PakistanKidney, Pakistan Kidney and Liver Institute and Research CenterSponsor-Investigator

Lead Sponsor

Nadeem IqbalOTHER

Collaborators

Name	Class
Ahmad Zia	UNKNOWN
Muhammad Junaid Tahir	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

158Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ceftriaxone Sodium	Drug	Antibiotic will be administered prophylactically for TACE	Antibiotic Prophylaxis Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmad Zia Ud Din, MBBS, FRCR	Contact	+923028099040		ahmad.zia@pkli.org.pk
Muhammad Junaid Tahir, MBBS, BSC	Contact			junaid262626@gmail.com

Overall Officials

Name	Affiliation	Role
Ahmad Zia Ud Din	PKLI & RC, Lahore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pakistan Kidney and Liver Institute	Recruiting	Lahore	Punjab Province	54000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 5, 2022	Dec 8, 2022	Prot_SAP_000.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D002443	Ceftriaxone

Ancestor Terms

ID	Term
D002439	Cefotaxime
D002505	Cephacetrile
D002511	Cephalosporins
D047090	beta-Lactams

Browse Leaves

Not provided

Browse Branches

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