NCT01659346撤回不适用
A Prospective Randomized Controlled Trial Comparing Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- First Variceal Bleeding
研究概览
简要总结
Every patient with HCC (Hepato-Cellular Carcinoma) with main portal vein thrombosis will be screened for presence of large esophageal varices and will be randomized between non-selective beta blocker versus primary endoscopic variceal ligation. They will be followed to assess the rate of reduction of index bleed rate as well as survival difference between the groups.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of cirrhosis with Hepatocellular carcinoma and portal vein thrombosis
- •Presence of large oesophageal varices or small with high risk
排除标准
- •Any contra-indication to beta-blockers
- •Any Endoscopic Variceal Ligation or Sclerotherapy within last 3 months
- •High risk gastric varices
- •Any past history of Transhepatic Intrajugular Portosystemic Shunt or surgery for portal hypertension
- •Significant cardio or pulmonary co-morbidity
- •Any extrahepatic malignancy
- •Patients with past history of variceal bleed
- •Patients with non-tumor portal vein thrombosis
- •Refusal to participate in the study
研究组 & 干预措施
Endoscopic Variceal Ligation
Experimental
Endoscopic Variceal Ligation every 3 weeks till eradication
干预措施: Endoscopic Variceal Ligation (Procedure)
Carvedilol
Active Comparator
Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD
干预措施: Carvedilol (Drug)
结局指标
主要结局
First Variceal Bleeding
时间窗: 1.5 years
次要结局
- Death(1.5 years)
- Procedure related complications.(1.5 years)
- Reappearance of Esophageal varices in presence of Portal Vein Thrombosis(1.5 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
ISP-TACE Versus TACE for HCC With PVTTPortal Vein Tumor ThrombosisHCCNCT03108248Zhongda Hospital126
已完成
不适用
Comparison of Treatment of Recurrent HCC With Repeat Hepatectomy,and TACE With AFP ConversionRecurrent Hepatocellular CarcinomaNCT02728219Eastern Hepatobiliary Surgery Hospital150
Unknown
2 期
A Randomized Phase II Trial of Surgery Plus Sorafenib vs. Sorafenib Alone for Hepatocellular Cancer (HCC) With Portal Vein InvasionHepatocellular CancerNCT03971201White Plains Hospital200
已完成
不适用
Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative NeoplasmsMyeloproliferative Neoplasms (MPN)Polycythemia Vera (PV)Essential Thrombocythemia (ET)Myelofibrosis (MF)NCT01816256University Health Network, Toronto102
Unknown
2 期
Randomized Control Trial (RCT) of Transarterial Chemoembolization (TACE) Versus TACE and Oral Drug Therapy in the Treatment of Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaNCT00522405All India Institute of Medical Sciences, New Delhi