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

Phase 4

• Conditions: Variceal Bleeding; Cirrhosis
• Interventions: Procedure: Endoscopic band ligation; Procedure: EBL+Propranolol; Drug: Propranolol

• Registration Number: NCT00965900
• Lead Sponsor: Korea University

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-25
• Study First Posted: 2009-08-26
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23
• Primary Completion: 2019-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 288

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic band ligation	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
EBL+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)
Propranolol	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)

Primary Outcome Measures

Name	Time	Method
First esophageal variceal bleeding	3 years after enrollment	First esophageal variceal bleeding after enrollment

Secondary Outcome Measures

Name	Time	Method
Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events	3 years after enrollment	Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of