Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma: a Study on the Proof of Treatment Concept and Exploration of Selection Criteria for Clinical Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The change in the perfusion pattern of HCC tumors
研究概览
简要总结
To prove the treatment concept of the use of balloon assistance in transarterial therapy for HCC.
详细描述
Transcatheter arterial chemoembolization (TACE) has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions of hepatocellular carcinoma (HCC) not eligible for surgical resection, transplantation, or local ablative therapy. The use of balloon assisted TACE has been proposed recently and it could be one of the possible ways to improve the effectiveness of drug delivery to the target tumor and therefore leading to improved treatment outcome.
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
- •Patients of age above 18 years
- •Patients who are indicated for transarterial treatment for HCC
- •Child-Pugh A or B cirrhosis
- •Eastern Cooperative Oncology Group performance score 0 or 1
- •BCLC A or B
- •No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
- •HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
- •No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen.
- •No invasion of portal vein or hepatic vein
- •Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions)
- •Total tumor mass < 50% liver volume
- •Size of any individual tumor <= 7cm in largest dimension
- •Serum creatinine < 130 umol/L or Creatinine clearance > 55 ml/min.
排除标准
- •Concurrent ischemic heart disease or heart failure
- •History of asthma, chronic obstructive airway disease or respiratory decompensation.
- •History of acute tumor rupture presenting with hemo-peritoneum
- •Biliary obstruction not amenable to percutaneous or endoscopic drainage
- •Child-Pugh C cirrhosis
- •History of hepatic encephalopathy
- •Intractable ascites not controllable by medical therapy
- •History of variceal bleeding within last 3 months
- •Serum total bilirubin level > 50 umol/L
- •Serum albumin level < 26 g/L
- •Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
- •Arterio-portal venous shunt affecting >1 hepatic segment on CT
- •Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
结局指标
主要结局
The change in the perfusion pattern of HCC tumors
时间窗: immediately after completion of procedure
The change in perfusion pressure.
The change in hemodynamics of arterial blood supply to HCC tumors
时间窗: immediately after completion of procedure
The change in number of feeding arteries
次要结局
- Tumor response(3 months)
研究者
Simon Yu
Professor
Chinese University of Hong Kong