跳至主要内容
临床试验/NCT03807947
NCT03807947Unknown不适用

Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

Humanitas Clinical and Research Center1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
74
试验地点
1
主要终点
Pain and discomfort during and after procedures

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients affected by HCC with indication to TAE from a multidisciplinary team discussion.

排除标准

  • •TAE for other malignancies or bleedings;
  • •Pregnancy.

研究组 & 干预措施

Radial access

Experimental

干预措施: Radial TAE - Bland embolization with 40-100 Microparticles (Procedure)

Transfemoral Access

Active Comparator

干预措施: Transfemoral TAE - Bland embolization with 40-100 Microparticles (Procedure)

结局指标

主要结局

Pain and discomfort during and after procedures

时间窗: 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.

次要结局

  • Access-related adverse events(0-48h after intervention.)

研究者

发起方
Humanitas Clinical and Research Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验