Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

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 Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma; Hepatocellular Carcinoma Non-resectable
• Intervention / Treatment: Procedure: Radial TAE - Bland embolization with 40-100 Microparticles; Procedure: Transfemoral TAE - Bland embolization with 40-100 Microparticles

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

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Rozzano, Lombardia, Italy, 20089
      • Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

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

Exclusion criteria

• TAE for other malignancies or bleedings;
• Pregnancy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Humanitas Clinical and Research Center
• Investigators: Principal Investigator: EZIO LANZA, MD, Humanitas Research Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: December 25, 2018
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; HCC; Embolization, Therapeutic; embolisation, therapeutic; TAE
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: ICHRadialTAE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No