Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

August 3, 2024 updated by: Ali Adel Abouelmagd Sewisy, Assiut University
Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization in terms of safety, feasibility, and procedural variables, including fluoroscopy time and patient preference.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Primary care clinics of Assuit university hospital.

Description

Inclusion Criteria:

  • Patients with Hepatocellular carcinoma of BCLC (Barcelona Clinic Liver Cancer) stage B
  • Also for BCLC stage A patients, in whom ablative therapy has technical limitations.
  • Downsizing tumor for resection or transplantation.

Exclusion Criteria:

  • Factors related to liver cirrhosis:

    • Decompensated cirrhosis (Child-Pugh B and C, score >8), including jaundice, clinical hepatic encephalopathy, and refractory ascites and/ or hepatorenal syndrome
    • Impaired portal-vein blood flow (portal-vein thrombus, hepatofugal blood flow)

  • Factors related to HCC:

    • Extensive tumor involving the entirety of both lobes of the liver
    • Malignant portal vein thrombosis
    • Extra-hepatic metastases

  • Impaired renal function:

    • Creatinine ≥2 mg/dl or creatinine clearance <30 ml/min

  • Factors related to procedure (Radial artery access):

    • Existing AV (arteriovenous) fistula or graft
    • Pervious major surgery to forearm or wrist
    • Vasculitis
    • Pervious access failure
    • Skin infection or compromised integrity
    • Artery size <2mm
    • Intolerance of hyperextended wrist positioning
    • Severe vasospasm
    • Vessel tortuosity
    • Radial loops
    • Absent or occluded radial artery
    • Atherosclerotic or calcific PAD (peripheral artery disease)
    • Coagulopathy INR>1.5 platelets count <50.000/mmc

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Transfemoral approach (TFA) group
Transradial approach (TRA) group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization
Time Frame: Baseline
To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization in terms of safety, feasibility, and procedural variables, including fluoroscopy time and patient preference.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 3, 2024

First Submitted That Met QC Criteria

August 3, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 3, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TACE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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