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临床试验/NCT01970748
NCT01970748招募中4 期

Endoscopic Treatment Versus Propranolol for Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
200
试验地点
1
主要终点
Bleeding

研究概览

简要总结

Randomized comparison within the endoscopic esophageal varices ligation versus non-selective beta-blocker in the primary prevention of esophageal variceal bleeding in patients with HCC.

详细描述

Gastroesophageal variceal bleeding is a major complication of cirrhosis and has high rate of rebleeding and mortality. In these 20 to 30 years, medical advances have significantly improved the prognosis of variceal bleeding. Nevertheless, the mortality of gastroesophageal variceal bleeding is still nearly 20 to 30%.

Hepatocellular carcinoma (HCC) is one of the most common malignancy in Asian, and is also the special group in portal hypertension. Studies in Italy, more than 50% of patients diagnosed with HCC are concomitant with esophageal varices. HCC and portal thrombosis caused by HCC itself are all independent risk factors of gastroesophageal bleeding. Once the bleeding, rebleeding rate is up to 50% even if early use of vasoconstrictor agents and endoscopic therapy, which is generally 2 times in patients with cirrhosis.

According to 2010 Baveno V recommendations, non-selective beta-blockers (NSBB) or endoscopic variceal ligation (EVL) are first choice for primary prevention of first variceal bleeding in cirrhotic patients. However, risk factors of variceal bleeding caused by HCC or cirrhosis are different, and portal hypertension is particularly high in patients with HCC and may be combined with portal vein thrombosis. NSBB sufficient to decreased portal hypertension to prevent variceal bleeding is not clear. In Hepatology 2010, Lebrec claimed that NSBB used for cirrhotic patients with refractory ascites had poor prognosis, the main cause of death were the progression of HCC and sepsis, although the impact of NSBB for HCC patients are not entirely clear, but this issue remind clinicians to careful use of NSBB in these patients. Since NSBB possible adverse effects, the use of EVL to prevent bleeding in patents with HCC is superior to NSBB? These need further study to clarify. So we designed this study to evaluate the feasibility and effectiveness of using EVL or NSBB to prevent first bleeding in patients with HCC concomitant with esophageal varices.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between 20 and 80 years old
  • Hepatocellular carcinoma (HCC) associated with esophageal varices
  • F2 or F3 esophageal varices (Beppu et al classification)
  • Hepatocellular carcinoma (HCC) associated with portal thrombosis

排除标准

  • History of esophageal variceal bleeding
  • Had received endoscopic variceal ligation (EVL) or endoscopic injection sclerotherapy (EIS)
  • Pregnancy, or the patients with other terminal illness (such as other terminal cancers, heart failure, renal failure...)
  • Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial disease...)

研究组 & 干预措施

Propranolol

Placebo Comparator

Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate>55 or systemic blood pressure>90mmHg)

干预措施: Propranolol (Drug)

Esophageal variceal ligation

Active Comparator

Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy. After eradication, follow-up endoscopy every 3 months and variceal ligation again if recurrence.

干预措施: Esophageal variceal ligation (Procedure)

结局指标

主要结局

Bleeding

时间窗: 2 years

次要结局

  • Complication survival(2 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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