Carvedilol vs Band Ligation vs Combination Therapy for Primary Prophylaxis of Variceal Bleeding
Status:
Withdrawn
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
Summary
Subjects will be those individuals greater than 18 years of age with a diagnosis of cirrhosis
undergoing screening for esophageal varices. Eligible subjects will have a diagnosis of
cirrhosis and esophageal varices (graded as medium or large) with no prior history of
variceal bleeding. The diagnosis of cirrhosis will be based on clinical, radiologic, and/or
laboratory data. Patients will be randomly assigned using electronic medical records to one
of three treatment arms after screening esophagogastroduodenoscopy (EGD) has been performed
and large varices are identified. Primary outcome of the study will be the incidence of
variceal bleeding in patients receiving one of the following therapies for primary
prophylaxis of variceal bleeding: carvedilol, variceal band ligation (VBL), or both
carvedilol and VBL.