Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis

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.

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.

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
• Refusal to give consent to participate in the trial