Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable
Conditions
Keywords
embolisation, therapeutic, Embolization, Therapeutic, Hepatocellular Carcinoma, HCC, TAE
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
Interventions
PROCEDURERadial TAE - Bland embolization with 40-100 Microparticles
TAE - Bland embolization with 40-100 Microparticles performed via left transradial access
PROCEDURETransfemoral TAE - Bland embolization with 40-100 Microparticles
TAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access
Sponsors
Humanitas Clinical and Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients affected by HCC with indication to TAE from a multidisciplinary team discussion.
Exclusion criteria
* TAE for other malignancies or bleedings; * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Access-related adverse events | 0-48h after intervention. | Complication at the site of access like hematoma or pseudoaneurysm |
Countries
Italy
Outcome results
None listed