Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT01383044 |
Other study ID # |
Carvedilol |
Secondary ID |
|
Status |
Terminated |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
July 8, 2011 |
Est. completion date |
June 30, 2020 |
Study information
Verified date |
November 2020 |
Source |
E-DA Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.