Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The aim of this prospective, randomized study is to compare TRA vs TFA for superselective embolization of HCC using bland microparticles performed by multiple operators. In particular, main objectives are to compare: the success rates of TRA and TFA including crossing over events between techniques the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization access-related adverse events patient preference and reported discomfort

Detailed Description
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Hepatic arterial chemoembolization is a safe, proven, and effective technique for the treatment of a number of malignancies, including primary and secondary tumors [1, 2]. This endovascular treatment is performed via femoral artery access in most cases. In the last decades, the transradial approach (TRA) has emerged as a valid alternative to the transfemoral approach (TFA), and it is commonly used in coronary angioplasty as well as stent placement. In particular, shorter monitoring time after the procedure, earlier ambulation, shorter hospital stay and less discomfort associated with potentially reduced bleeding risks make TRA an attractive alternative to TFA. To date, only one study exists comparing TRA vs TFA in liver embolizations [3]. However, it is non-randomized and reports only the outcomes of one operator performing lobar embolization for multiple liver malignancies. The aim of this prospective, randomized study is to compare TRA vs TFA for superselective embolization of HCC using bland microparticles performed by multiple operators. In particular, main objectives are to compare: the success rates of TRA and TFA including crossing over events between techniques the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization access-related adverse events patient preference and reported discomfort

Official Title
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Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable

Intervention / Treatment
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* Procedure: Radial TAE - Bland embolization with 40-100 Microparticles
* Procedure: Transfemoral TAE - Bland embolization with 40-100 Microparticles


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: patients affected by HCC with indication to TAE from a multidisciplinary team discussion. Exclusion criteria TAE for other malignancies or bleedings; Pregnancy.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radial access<br> | Procedure: Radial TAE - Bland embolization with 40-100 Microparticles<br>* TAE - Bland embolization with 40-100 Microparticles performed via left transradial access<br>|
| Active Comparator: Transfemoral Access<br> | Procedure: Transfemoral TAE - Bland embolization with 40-100 Microparticles<br>* TAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and discomfort during and after procedures | Questionnaire with four questions with 5 a points scale describing pain and discomfort during and after procedure, where 0 is the minimum and 4 the maximum. | 24 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access-related adverse events | Complication at the site of access like hematoma or pseudoaneurysm | 0-48h after intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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embolisation, therapeutic, Embolization, Therapeutic, Hepatocellular Carcinoma, HCC, TAE