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slow enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVL + carvedilol | Experimental | EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day |
|
| carvedilol | Active Comparator | carvedilol 6.25-12.5 mg per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVL + carvedilol | Procedure | EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| patients with first bleeding | the difference of bleeding episode in both groups. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| patients with complications and mortality rates | the difference of complications & survival curve between both groups. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| E-DA hospital | Kaogsiung | 82445 | Taiwan |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| carvedilol | Drug | carvedilol 6.25mg-12.5 mg per day |
|
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |