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

Korea University

Status and phase: Unknown; Phase 4

Conditions: Cirrhosis; Variceal Bleeding

Treatments: Procedure: Endoscopic band ligation; Drug: Propranolol; Procedure: EBL+Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT00965900

RCTPEBL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

288 participants in 3 patient groups

Endoscopic band ligation

Active Comparator group

Description:

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

Treatment:

Procedure: Endoscopic band ligation

Propranolol

Active Comparator group

Description:

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)

Treatment:

Drug: Propranolol

EBL+Propranolol

Active Comparator group

Description:

* 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)

Treatment:

Procedure: EBL+Propranolol