Comparative Study of Carvedilol Monotherapy Versus Combination Therapy With Endoscopic Variceal Ligation (EVL) for Primary Prophylaxis of Variceal Bleeding in Patients With Hepatocellular Carcinoma With High-Risk Esophageal Varices: A Randomized Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the efficacy of combination of Carvedilol with EVL over Carvedilol in prevention of index variceal bleed in a period of 6 months follow up among cirrhosis patients with HCC and high risk esophageal varices.
研究概览
简要总结
Esophageal varices are common in patients with hepatocellular carcinoma (HCC), with an incidence rate of 63% at the time of HCC diagnosis. Following an acute variceal bleed, the 6-week mortality rate for HCC patients is as high as 26%. Mortality rates escalate notably in HCC patients experiencing acute variceal bleeding, especially with increasing cancer severity indicated by BLCL status. Research suggests that the cumulative incidence rate of variceal bleeding at one year in patients receiving primary prophylaxis is almost half that of patients not receiving any prophylaxis.
Beta blockers are the standard therapy for primary prophylaxis in patients with portal hypertension to prevent variceal bleeding. Endoscopic band ligation has also shown promising results in recent studies. However, the combined impact of beta blockers and esophageal band ligation on lowering the incidence of variceal bleeding remains unstudied.
The aim of this study is to compare the efficacy of carvedilol monotherapy versus combination therapy with carvedilol and endoscopic band ligation in patients with HCC for primary prophylaxis of high-risk esophageal varices.
Study population: All patients aged more than equals to 18 years and less than equals to 80 years admitted in Institute of Liver and Biliary Sciences, New Delhi with HCC of any cause and high risk esophageal varices and are giving written consent for participation in the study.
Study design - Single center, Open label, Randomized controlled trial
Study period – 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18-80 years
- •Cirrhosis with HCC
- •High risk oesophageal varices (large or small with RCS)
- •Valid consent.
排除标准
- •Any contra-indication to beta-blockers
- •Any EVL or Sclerotherapy within last 3 months
- •Any past history of TIPS or surgery for portal hypertension
- •HCC with BCLC-D
- •Patients with past history of variceal bleed.
- •Patient With Liver transplant expected in next 2 weeks would be excluded.
结局指标
主要结局
To compare the efficacy of combination of Carvedilol with EVL over Carvedilol in prevention of index variceal bleed in a period of 6 months follow up among cirrhosis patients with HCC and high risk esophageal varices.
时间窗: 6 months
次要结局
- To study the impact of TKI/Immunotherapy on variceal bleed.(6 months)
- To study the impact of PVTT on Variceal bleed(6 months)
- Post EVL Ulcer bleed incidence and outcome(6 months)
- To study effect of beta blocker on non invasive test for portal hypertension -LSM, SSM, APRI Score, ALBI Score and FIB-4,D-Dimer.(6 months)
- To study impact of locoregional therapy like SBRT on variceal bleed.(6 months)
研究者
Dr Sarthak Chanana
Institute of Liver and Biliary Sciences