NCT00965900

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Korea University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Variceal Bleeding
• Cirrhosis

Interventions

Type	Name	Description
PROCEDURE	Endoscopic band ligation	* Perform EBL within 7 days after randomization * Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (at 4,8,12 weeks after initial treatment) * Acid suppression using proton pump inhibitor until eradicated. * After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months).
DRUG	Propranolol	* start with 20 mg of propranolol b.i.d * Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 55/min * After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
PROCEDURE	EBL+Propranolol	1. EBL * Perform EBL within 7 days after randomization * Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (at 4,8,12 weeks after initial treatment) * Acid suppression using proton pump inhibitor until eradicated. * After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months). 2. Propranolol * start with 20 mg b.i.d * Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 55/min * After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)

Timeline

• Start date: 2006-09-01
• Primary completion: 2019-05-01
• Completion: 2021-05-01
• First posted: 2009-08-26
• Last updated: 2017-08-23

Locations

1 site across 1 country: South Korea