Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Humanitas Clinical and Research Center
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Pain and discomfort during and after procedures
- Last Updated
- 7 years ago
Overview
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:
- the success rates of TRA and TFA including crossing over events between techniques
- the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization
- access-related adverse events
- 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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pain and discomfort during and after procedures
Time Frame: 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 Outcomes
- Access-related adverse events(0-48h after intervention.)