Recruitment

Recruitment Status
Recruiting

Inclusion Criterias

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
Hepatocellular carcinoma (HCC) associated with portal thrombosis
Hepatocellular carcinoma (HCC) associated with esophageal varices
F2 or F3 esophageal varices (Beppu et al classification)

Exclusion Criterias

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
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)
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 Criterias

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
Hepatocellular carcinoma (HCC) associated with portal thrombosis
Hepatocellular carcinoma (HCC) associated with esophageal varices
F2 or F3 esophageal varices (Beppu et al classification)

Exclusion Criterias

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
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)
Pregnancy, or the patients with other terminal illness (such as other terminal cancers, heart failure, renal failure...)

Locations

Taipei, 11217
Taipei, 11217

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