Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

Not Applicable

• Conditions: Hepatocellular Carcinoma; Hepatocellular Carcinoma Non-resectable
• Interventions: Procedure: Transfemoral TAE - Bland embolization with 40-100 Microparticles; Procedure: Radial TAE - Bland embolization with 40-100 Microparticles

• Registration Number: NCT03807947
• Lead Sponsor: Humanitas Clinical and Research Center

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

Study Timeline

• Study First Submitted: 2018-12-25
• Status Verified: 2019-01
• Study Start: 2019-01
• Study First Submitted QC: 2019-01-16
• Last Update Submitted: 2019-01-16
• Study First Posted: 2019-01-17
• Last Update Posted: 2019-01-17
• Primary Completion: 2019-12
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transfemoral Access	Transfemoral TAE - Bland embolization with 40-100 Microparticles	-
Radial access	Radial TAE - Bland embolization with 40-100 Microparticles	-

Primary Outcome Measures

Name	Time	Method
Pain and discomfort during and after procedures	24 hours after intervention	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.

Secondary Outcome Measures

Name	Time	Method
Access-related adverse events	0-48h after intervention.	Complication at the site of access like hematoma or pseudoaneurysm

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, Lombardia, Italy