Feasibility and Clinical Outcome of TIPS Combined With Subsequent Microwave Ablation in HCC Patients With Refractory Ascites
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- overall survival (OS)
研究概览
简要总结
Transjugular intrahepatic portosystemic shunt (TIPS) could effectively decrease portal hypertension-related complications. This study intends to evaluate the efficacy and safety of TIPS combined with subsequent microwave ablation in HCC patients with refractory ascites.
详细描述
Hepatocellular carcinoma (HCC) patients with refractory ascites (RA) have a very poor prognosis, and there are no effective treatments recommended by the guidelines. TIPS could downgrade the ascites and improve Child-Pugh scores. TIPS has been a common management model for RA for end-stage liver disease. There is no prospective study evaluating TIPS plus thermal ablation. Thus, the investigators carried out this prospective, single-arm study to find out it.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-70 years
- •Diagnosis of HCC based on the European Association for the Study of the Liver
- •Tumor diameter ≤ 3cm
- •Refractory ascites based on International Ascites Club: (a) intensive diuretics (spironolactone 400 mg/d combined with furosemide 160 mg/d) and sodium-restricted diet (<90 mmoVd) for at least 1 week have no response; (b) lack of response to diuretic therapy; (c) early recurrence of ascites within 4 weeks; (d) Diuretic-induced complications. The grading of ascites was divided into mild ascites, moderate ascites, and large or gross ascites
排除标准
- •Congestive heart failure or severe valvular heart failure
- •Uncontrolled systemic infection or inflammation
- •Macroscopic vascular invasion or extrahepatic metastasis
- •Severe pulmonary hypertension
- •Severe renal insufficiency (except hepatogenic renal insufficiency) (6) rapidly progressive liver failure
- •Diffuse malignant liver tumor
- •Contrast agent allergy
结局指标
主要结局
overall survival (OS)
时间窗: 24 months
the interval from TIPS to death or lost to follow-up
次要结局
- change in Child-Pugh scores(6 months)
- Incidence of hepatic encephalopathy(24 months)
- Varices rebleeding rate(24 months)
- change in Child-Pugh stage(6 months)
研究者
Zhou Qunfang
Professor
Sun Yat-sen University