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Brief Title: Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma
Official Title: Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma
Study ID: NCT03807947
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
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Humanitas Research Hospital, Rozzano, Lombardia, Italy
Name: EZIO LANZA, MD
Affiliation: Humanitas Research Hospital
Role: PRINCIPAL_INVESTIGATOR