Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03807947
Status:
UNKNOWN
Last Update Posted:
2019-01-17
First Post:
2018-12-25
Brief Title:
Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma
Sponsor:
Humanitas Clinical and Research Center
Organization:
Humanitas Clinical and Research Center
Study Overview
Official Title:
Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None