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Lack of enrollment
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Patients with scarring of the liver (cirrhosis) and portal hypertension (elevated blood pressure in the liver vasculature) can develop esophageal varices (dilated veins). These have an increased risk of bleeding each year. Current recommendations are to prevent bleeding of medium or large varices (when there is no history of bleeding) by starting a blood pressure lowering agent known as a non-selective beta-blocker. Alternatively, rubber bands can be placed on medium to large varices to prevent bleeding (endoscopic variceal band ligation). Using both therapies at the same time has not been studied. In this study, we hope to determine if the use of combination therapy with endoscopic variceal band ligation and beta blockers is more effective than using beta blockers alone to prevent the first bleeding episode from the varices (dilated veins). The efficacy, ability to tolerate, and cost-effectiveness of these two treatment strategies will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | endoscopic variceal band ligation |
|
| 2 | Active Comparator | subjects will receive nadolol (beta blocker) at 20mg/day with dose titration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic variceal band ligation | Procedure | endoscopic variceal band ligation |
|
| Measure | Description | Time Frame |
|---|---|---|
| first variceal bleed | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| survival | 2 years | |
| liver function | 1 year | |
| encephalopathy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arun J Sanyal, M.D. | Division of Gastroenterology, Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Term |
|---|---|
| D004932 | Esophageal and Gastric Varices |
| D014648 | Varicose Veins |
| D006975 | Hypertension, Portal |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| 1 year |
| quality of life | 1 year |
| frequency of other complications of cirrhosis | 2 years |
| cost utility | 1 year |
| patient preference | 1 year |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |