Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03807947
• Other study ID #: ICHRadialTAE
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2019
• Est. completion date: April 2020

Study information

• Verified date: January 2019
• Source: Humanitas Clinical and Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: April 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion criteria:

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

Exclusion criteria

• TAE for other malignancies or bleedings;

• Pregnancy.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Hepatocellular Carcinoma Non-resectable

Intervention

Procedure:
• Radial TAE - Bland embolization with 40-100 Microparticles
TAE - Bland embolization with 40-100 Microparticles performed via left transradial access
• Transfemoral TAE - Bland embolization with 40-100 Microparticles
TAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Humanitas Clinical and Research Center

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Access-related adverse events	Complication at the site of access like hematoma or pseudoaneurysm	0-48h after intervention.