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临床试验/NCT04641637
NCT04641637已完成不适用

Substudy of Protocol TACE Emulsion Versus Suspension (NCT03268499): Interconnection of Arterial Tumor Feeders Through Tumor Sinusoid in Hepatocellular Carcinoma(HCC): In-vivo Proof of Concept and Clinical Implication

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
The completeness of coverage of the tumor vasculature by therapeutic agent at the completion of the treatment as evaluated on non-contrast CT scan

研究概览

简要总结

It is postulated that all arterial tumor feeders supplying a HCC tumor are interconnected with each other through the tumor sinusoid, such that when one of the feeders is catheterized for delivery of a liquid embolic agent, the whole tumor sinusoid will be embolized, if the arterial blood flow in all the other feeders are stopped temporarily to create a negative pressure gradient.

详细描述

Selective catheterization of segmental or more peripheral arteries in the procedure of transarterial treatment could be crucial in making a significant difference in survival outcome (1). Subsegmental chemoembolization (TACE) leading to portal vein visualization is associated with a higher chance of complete response (2), and complete response is a robust predictor of better overall survival (3). Selective TACE might also help to preserve liver function because TACE damages liver parenchyma and repeated TACE could lead to deterioration in liver function (4). In a procedure of ultra-selective TACE, each of the arterial tumor feeders is supposed to be catheterized for complete treatment of the whole tumor when there are multiple tumor feeders (5), it could be time consuming and technically challenging to achieve catheterize all the tumor feeders at a sub-subsegmental level when difficult arterial anatomy is encountered, even with the guidance of a automated tumor-feeders detection software (6). In the angioarchitecture of HCC, arterial tumor feeders lead to tumor sinusoid which is an interconnected network of vascular channel within the tumor substance (7). It is postulated that all arterial tumor feeders supplying a HCC tumor are interconnected with each other through the tumor sinusoid, such that when one of the feeders is catheterized for delivery of a liquid embolic agent, the whole tumor sinusoid will be embolized, if the arterial blood flow in all the other feeders are stopped temporarily to create a negative pressure gradient.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Child-Pugh grade A, HCC diagnosed with typical arterial enhancement and portal washout patterns on contrast enhanced CT or MRI, solitary tumor, hypervascularity, well-defined margin, size ≤7cm, at least two arterial tumor feeders on CT scan

排除标准

  • 未提供

研究组 & 干预措施

Selective catheterization of segmental or more peripheral arteries in TACE

Other

From the digital subtraction angiography (DSA), the number of arterial tumor feeders to the HCC is identified. One or more feeder(s) is to be catheterized for delivery of therapeutic agent using a 2.4 French microcatheter (Merit Maestro, Merit Medical Systems, Utah, USA), and the other feeder(s) is occluded with a balloon catheter using 0.1 to 0.2mL diluted contrast for inflation (4mm x 10mm Temporary Occlusion Balloon Catheter, Occlusafe, Terumo Clinial Supply, Gifu, Japan). The occlusion target could be a feeder or a common trunk leading to a number of feeders.

干预措施: TACE (Procedure)

结局指标

主要结局

The completeness of coverage of the tumor vasculature by therapeutic agent at the completion of the treatment as evaluated on non-contrast CT scan

时间窗: immediately after completion of procedure

The completeness of coverage of the tumor vasculature by therapeutic agent at the completion of the treatment as evaluated on non-contrast CT scan

次要结局

  • Tumor response(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Yu

Professor

Chinese University of Hong Kong

研究点 (1)

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