Transarterial Drug-Eluting Chemoembolization for HCC Patients in Korea Using Transradial Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Technical Success Rate
研究概览
简要总结
This study is a prospective, observational clinical trial designed to evaluate the feasibility, safety, and effectiveness of performing transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) using a transradial arterial approach. Traditionally, TACE procedures are performed through the femoral artery in the groin, but using the radial artery in the wrist may reduce complications, improve patient comfort, and allow for faster recovery.
In this study, eligible patients with unresectable HCC who meet the inclusion criteria-such as preserved liver function (Child-Pugh A), good performance status, and tumors of a certain size and number-will undergo TACE using HepaSphere drug-eluting embolic materials via radial access. No randomization or drug intervention will be assigned by protocol, as the treatment will follow standard clinical practice.
The study will follow participants for 12 months to assess technical success, tumor response using imaging criteria (mRECIST), safety outcomes including adverse events, and overall survival. The study is being conducted at Asan Medical Center in Seoul, Korea, and has received Institutional Review Board approval.
详细描述
This is a prospective observational study to evaluate the feasibility, safety, and tumor response of transarterial chemoembolization (TACE) using a transradial approach in patients with hepatocellular carcinoma (HCC). Eligible patients will undergo drug-eluting beads TACE via radial access and be followed for up to 12 months. The primary outcome is the technical success rate of the procedure. Secondary outcomes include survival rate, tumor response by mRECIST, and adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Age between 19 and 80 years
- •Diagnosed with hepatocellular carcinoma (HCC)
- •Child-Pugh class A
- •ECOG performance status 0 or 1
- •Tumor size between 3 and 10 cm, with 1 to 7 nodules
- •Ability to provide written informed consent
排除标准
- •Child-Pugh class B or C
- •Presence of other malignancies
- •CKD stage 4 or 5 (eGFR < 30 mL/min/1.73m²)
- •Known allergy or contraindication to contrast media
- •Pregnancy or breastfeeding
结局指标
主要结局
Technical Success Rate
时间窗: Immediately after the procedure
Defined as successful completion of the planned transarterial chemoembolization (TACE) procedure using transradial access without conversion to transfemoral access.
次要结局
- Incidence of Adverse Events(Within 30 days of procedure)
- Tumor Response Rate Based on mRECIST(1-3 months post-treatment)
研究者
Jihoon Kim
Professor, Department of Radiology
Asan Medical Center