Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

Humanitas Clinical and Research Center

Status: Unknown

Conditions: Hepatocellular Carcinoma Non-resectable; Hepatocellular Carcinoma

Treatments: Procedure: Transfemoral TAE - Bland embolization with 40-100 Microparticles; Procedure: Radial TAE - Bland embolization with 40-100 Microparticles

Study type: Interventional

Funder types: Other

Identifiers

NCT03807947

ICHRadialTAE

Details and patient eligibility

About

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:

1. the success rates of TRA and TFA including crossing over events between techniques
2. the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization
3. access-related adverse events
4. patient preference and reported discomfort

Full description

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:

1. the success rates of TRA and TFA including crossing over events between techniques
2. the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization
3. access-related adverse events
4. patient preference and reported discomfort

Enrollment: 74 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• patients affected by HCC with indication to TAE from a multidisciplinary team discussion.

Exclusion criteria

• TAE for other malignancies or bleedings;
• Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Radial access

Experimental group

Treatment:

Procedure: Radial TAE - Bland embolization with 40-100 Microparticles

Transfemoral Access

Active Comparator group

Treatment:

Procedure: Transfemoral TAE - Bland embolization with 40-100 Microparticles