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Sponsored by: |
Virginia Commonwealth University |
Information provided by: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00409084 |
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.
Condition | Intervention | Phase |
Esophageal Varices |
Procedure: endoscopic variceal band ligation |
Phase III |
MedlinePlus related topics: | Cirrhosis Endoscopy Esophagus Disorders High Blood Pressure Varicose Veins |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding |
Estimated Enrollment: | 80 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
1: Active Comparator
endoscopic variceal band ligation
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Procedure: endoscopic variceal band ligation
endoscopic variceal band ligation
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2: Active Comparator
subjects will receive nadolol (beta blocker) at 20mg/day with dose titration
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Procedure: endoscopic variceal band ligation
endoscopic variceal band ligation
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Arun J Sanyal, M.D. | 804 828 6314 | ajsanyal@hsc.vcu.edu |
Contact: Amrita Sethi, M.D. | 804 828 6314 | asethi@vcu.edu |
United States, Virginia | |||||
Virginia Commonwealth University | Recruiting | ||||
Richmond, Virginia, United States, 23298 | |||||
Contact: Arun J Sanyal, M.D. 804-828-6314 ajsanyal@hsc.vcu.edu | |||||
Contact: Amrita Sethi, M.D. 804 828 6314 asethi@vcu.edu | |||||
Principal Investigator: Arun J Sanyal, M.D. |
Virginia Commonwealth University |
Principal Investigator: | Arun J Sanyal, M.D. | Division of Gastroenterology, Virginia Commonwealth University |
Responsible Party: | Virginia Commonwealth University ( Arun J. Sanyal, MD ) |
Study ID Numbers: | HM10546 |
First Received: | December 6, 2006 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00409084 |
Health Authority: | United States: Institutional Review Board |
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