Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis
Overview
- Phase
- Phase 4
- Intervention
- Endoscopic band ligation
- Conditions
- Variceal Bleeding
- Sponsor
- Korea University
- Enrollment
- 288
- Locations
- 1
- Primary Endpoint
- First esophageal variceal bleeding
- Last Updated
- 8 years ago
Overview
Brief Summary
This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.
Detailed Description
Current guidelines recommend prophylactic treatment with propranolol or endoscopic band ligation (EBL) to prevent variceal bleeding in patients with medium or large varices. However, it is unclear which treatment is more useful in regard to prevention of variceal bleeding as well as safety. In addition, the efficacy and safety of the combination of EBL and propranolol is not still defined. This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.
Investigators
Soon Ho Um
Professor
Korea University
Eligibility Criteria
Inclusion Criteria
- •Liver cirrhosis
- •Age between 18 and 70 years
- •Esophageal varices with high bleeding risk: more than F2 and red color sign
- •No previous history of upper gastrointestinal bleeding
- •No previous history of endoscopic, radiologic, or surgical therapy for varices or ascites
- •Do not take beta-blocker, ACE inhibitor, or nitrate
- •Child-Pugh score \<12
Exclusion Criteria
- •Patients with systolic blood pressure \<100 mmHg or basal heart rate \<60/min
- •Portal vein thrombosis
- •Uncontrolled ascites or hepatic encephalopathy
- •Severe coagulation disorder: prothrombin time \<40% (or INR \>1.7) or platelet count \<30,000/mm3
- •Medium or large sized gastric or duodenal varices
- •Coexisting malignancy
- •Severe cardiovascular disorder, renal failure, peritonitis, sepsis
- •Severe erosive esophagitis, severe esophageal stricture, active gastric or duodenal ulcer
- •Contraindication to beta-blocker
- •Pregnancy
Arms & Interventions
Endoscopic band ligation
Endoscopic band ligation until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment
Intervention: Endoscopic band ligation
Propranolol
start with 20 mg b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
Intervention: Propranolol
EBL+Propranolol
* EBL until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment * start with 20 mg of propranolol b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
Intervention: EBL+Propranolol
Outcomes
Primary Outcomes
First esophageal variceal bleeding
Time Frame: 3 years after enrollment
First esophageal variceal bleeding after enrollment
Secondary Outcomes
- Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events(3 years after enrollment)