NCT03807947

Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Humanitas Clinical and Research Center · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Radial TAE - Bland embolization with 40-100 Microparticles	TAE - Bland embolization with 40-100 Microparticles performed via left transradial access
PROCEDURE	Transfemoral TAE - Bland embolization with 40-100 Microparticles	TAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-12-01
• Completion: 2020-04-01
• First posted: 2019-01-17
• Last updated: 2019-01-17

Locations

1 site across 1 country: Italy