Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices
Last updated on April 2022Recruitment
- Recruitment Status
- Recruiting
Inclusion Criteria
- Hepatocellular carcinoma (HCC) associated with portal thrombosis
- Hepatocellular carcinoma (HCC) associated with esophageal varices
- Between 20 and 80 years old
- ...
- Hepatocellular carcinoma (HCC) associated with portal thrombosis
- Hepatocellular carcinoma (HCC) associated with esophageal varices
- Between 20 and 80 years old
- F2 or F3 esophageal varices (Beppu et al classification)
Exclusion Criteria
- Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial disease...)
- Had received endoscopic variceal ligation (EVL) or endoscopic injection sclerotherapy (EIS)
- History of esophageal variceal bleeding
- ...
- Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial disease...)
- Had received endoscopic variceal ligation (EVL) or endoscopic injection sclerotherapy (EIS)
- History of esophageal variceal bleeding
- Pregnancy, or the patients with other terminal illness (such as other terminal cancers, heart failure, renal failure...)
Summary
- Conditions
- Bleeding Esophageal Varices
- Hepatocellular Carcinoma
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 80 years
- Gender
- Both males and females
Description
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 ...
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.
Inclusion Criteria
- Hepatocellular carcinoma (HCC) associated with portal thrombosis
- Hepatocellular carcinoma (HCC) associated with esophageal varices
- Between 20 and 80 years old
- ...
- Hepatocellular carcinoma (HCC) associated with portal thrombosis
- Hepatocellular carcinoma (HCC) associated with esophageal varices
- Between 20 and 80 years old
- F2 or F3 esophageal varices (Beppu et al classification)
Exclusion Criteria
- Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial disease...)
- Had received endoscopic variceal ligation (EVL) or endoscopic injection sclerotherapy (EIS)
- History of esophageal variceal bleeding
- ...
- Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial disease...)
- Had received endoscopic variceal ligation (EVL) or endoscopic injection sclerotherapy (EIS)
- History of esophageal variceal bleeding
- Pregnancy, or the patients with other terminal illness (such as other terminal cancers, heart failure, renal failure...)
Tracking Information
- NCT #
- NCT01970748
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ming-Chih Hou, MD Taipei Veterans General Hospital, Taiwan
- Ming-Chih Hou, MD Taipei Veterans General Hospital, Taiwan