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Clinical Trials/NCT03807947
NCT03807947
Unknown
Not Applicable

Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

Humanitas Clinical and Research Center1 site in 1 country74 target enrollmentJanuary 2019

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:

  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

Registry
clinicaltrials.gov
Start Date
January 2019
End Date
April 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Humanitas Clinical and Research Center
Responsible Party
Sponsor

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.)

Study Sites (1)

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