Radial Versus Femoral Access for Superselective Embolization of

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Carcinoma
Carcinoma, Hepatocellular
Hepatocellular Carcinoma
Hepatocellular Carcinoma Non-resectable

Clinical Trial Details

NCT number	NCT03807947
Study type	Interventional
Source	Humanitas Clinical and Research Center
Contact
Status	Not yet recruiting
Phase	N/A
Start date	January 2019
Completion date	April 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms