A multi-center randomized controlled study of primary prevention of esophageal variceal bleeding in cirrhotic patients treated with HVPG-guided beta- blocker therapy or standard heart rate-guided beta-blocker therapy.
Completed
- Conditions
- Esophageal variceal bleedingesophageal variceal hemorrhage100179591001965410043413
- Registration Number
- NL-OMON55566
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
Inclusion Criteria
Liver cirrhosis
Esophageal varices >=5 mm, no prior variceal bleeding
Patient age 18 years or older
Exclusion Criteria
Contraindications to beta-blocker therapy
Pregnancy
Prior variceal hemorrhage
Esophageal varices in the absence of liver cirrhosis
Intermediate, advanced or terminal stage hepatocellular carcinoma (BCLC stage
B, C or D)
Refractory ascites
Hepatorenal syndrome
Prior treatment or prophylaxis for esophageal varices or esophageal variceal
bleedings (propranolol use, TIPS, endoscopic bandligation, endoscopic
sclerotherapy)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>First variceal bleeding episodes occurring within the first two years.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Mortality<br /><br>Occurrence of other cirrhosis-related complications<br /><br>Occurrence of hepatocellular carcinoma<br /><br>Costs of treatments<br /><br>Adverse effects</p><br>