Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

NCT ID: NCT03807947

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2020-04-30

Brief 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

Detailed 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

Conditions

Hepatocellular Carcinoma; Hepatocellular Carcinoma Non-resectable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radial access

Group Type: EXPERIMENTAL

Radial TAE - Bland embolization with 40-100 Microparticles

Intervention Type: PROCEDURE

TAE - Bland embolization with 40-100 Microparticles performed via left transradial access

Transfemoral Access

Group Type: ACTIVE_COMPARATOR

Transfemoral TAE - Bland embolization with 40-100 Microparticles

Intervention Type: PROCEDURE

TAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access

Interventions

Radial TAE - Bland embolization with 40-100 Microparticles

TAE - Bland embolization with 40-100 Microparticles performed via left transradial access

Intervention Type: PROCEDURE

Transfemoral TAE - Bland embolization with 40-100 Microparticles

TAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Humanitas Clinical and Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EZIO LANZA, MD

Role: PRINCIPAL_INVESTIGATOR

Humanitas Research Hospital IRCCS, Rozzano-Milan

Locations

Humanitas Research Hospital

Rozzano, Lombardy, Italy

Countries

Italy

References

Iezzi R, Pompili M, Posa A, Annicchiarico E, Garcovich M, Merlino B, Rodolfino E, Di Noia V, Basso M, Cassano A, Barone C, Gasbarrini A, Manfredi R, Colosimo C. Transradial versus Transfemoral Access for Hepatic Chemoembolization: Intrapatient Prospective Single-Center Study. J Vasc Interv Radiol. 2017 Sep;28(9):1234-1239. doi: 10.1016/j.jvir.2017.06.022. Epub 2017 Jul 27.

Reference Type: BACKGROUND

PMID: 28757286 (View on PubMed)

Other Identifiers

ICHRadialTAE

Identifier Type: -

Identifier Source: org_study_id