Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Radial TAE - Bland embolization with 40-100 Microparticles
Transfemoral TAE - Bland embolization with 40-100 Microparticles
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring embolisation, therapeutic, Embolization, Therapeutic, Hepatocellular Carcinoma, HCC, TAE
Eligibility Criteria
Inclusion criteria:
- patients affected by HCC with indication to TAE from a multidisciplinary team discussion.
Exclusion criteria
- TAE for other malignancies or bleedings;
- Pregnancy.
Sites / Locations
- Humanitas Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Radial access
Transfemoral Access
Arm Description
Outcomes
Primary Outcome Measures
Pain and discomfort during and after procedures
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 Outcome Measures
Access-related adverse events
Complication at the site of access like hematoma or pseudoaneurysm
Full Information
NCT ID
NCT03807947
First Posted
December 25, 2018
Last Updated
January 16, 2019
Sponsor
Humanitas Clinical and Research Center
1. Study Identification
Unique Protocol Identification Number
NCT03807947
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 Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Humanitas Clinical and Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable
Keywords
embolisation, therapeutic, Embolization, Therapeutic, Hepatocellular Carcinoma, HCC, TAE
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radial access
Arm Type
Experimental
Arm Title
Transfemoral Access
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Radial TAE - Bland embolization with 40-100 Microparticles
Intervention Description
TAE - Bland embolization with 40-100 Microparticles performed via left transradial access
Intervention Type
Procedure
Intervention Name(s)
Transfemoral TAE - Bland embolization with 40-100 Microparticles
Intervention Description
TAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access
Primary Outcome Measure Information:
Title
Pain and discomfort during and after procedures
Description
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.
Time Frame
24 hours after intervention
Secondary Outcome Measure Information:
Title
Access-related adverse events
Description
Complication at the site of access like hematoma or pseudoaneurysm
Time Frame
0-48h after intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
patients affected by HCC with indication to TAE from a multidisciplinary team discussion.
Exclusion criteria
TAE for other malignancies or bleedings;
Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EZIO LANZA, MD
Organizational Affiliation
Humanitas Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humanitas Research Hospital
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28757286
Citation
Iezzi R, Pompili M, Posa A, Annicchiarico E, Garcovich M, Merlino B, Rodolfino E, Di Noia V, Basso M, Cassano A, Barone C, Gasbarrini A, Manfredi R, Colosimo C. Transradial versus Transfemoral Access for Hepatic Chemoembolization: Intrapatient Prospective Single-Center Study. J Vasc Interv Radiol. 2017 Sep;28(9):1234-1239. doi: 10.1016/j.jvir.2017.06.022. Epub 2017 Jul 27.
Results Reference
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Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma
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