NCT01383044

Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding

Banding Ligation With Carvedilol vs. Carvedilol for the Prevention of First Bleeding in Cirrhotics With Moderate Varices

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: E-DA Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in prophylaxis of the first bleeding. The efficacy \& safety of combining EVL and carvedilol in prophylaxis of the first bleeding is still unknown. This study aims to investigate the value of combination therapy.

Detailed description

Combination of EVL and β-blocker has been proven effective in the prevention of variceal rebleeding . However, Our previous study showed that combination of EVL and nadolol do not have enhanced effect in the prophylaxis of 1st variceal bleeding as compared with nadolol alone . One of the drawbacks of EVL is esophageal ulcer. On the other hand ,carvedilol, an anti-α beta-blocker, has been proven to be more effective than propranolol in the reduction of portal pressure. Carvedilol has been proven to be more effective than EVL in the prevention of 1st variceal bleeding. The investigators thus conduct a multicenter trial to evaluate whether combination of EVL and carvedilol could be more effective than carvedilol alone in the prophylaxis of 1st esophageal variceal bleeding . The goal of patients receiving EVL is to reduce variceal size, not variceal obliteration, in anticipation for fewer sessions required for each patient and fewer possibility of esophageal ulcer bleeding.

Conditions

• Variceal Bleeding

Interventions

Type	Name	Description
PROCEDURE	EVL + carvedilol	EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day
DRUG	carvedilol	carvedilol 6.25mg-12.5 mg per day

Timeline

• Start date: 2011-07-08
• Primary completion: 2015-07-30
• Completion: 2020-06-30
• First posted: 2011-06-28
• Last updated: 2020-11-20

Locations

1 site across 1 country: Taiwan