Carvedilol vs Band Ligation vs Combination Therapy for Primary Prophylaxis of Variceal Bleeding

• Status: Withdrawn
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

• Inclusion criteria for the study will be an individual > 18 years old with a diagnosis of cirrhosis (either by history, serology or imaging), with medium or large esophageal varices on variceal screening esophagogastroduodenoscopy (EGD), and no prior history of gastrointestinal (GI) bleeding, as related to portal hypertension

Exclusion Criteria:

• Exclusion criteria will be the following: pregnant females; patients on beta blockers or nitrates for any underlying condition; allergies to carvedilol; mean arterial pressure < 55 mm Hg or pulse < 55 beats per minute at baseline; presence of hepatocellular carcinoma; presence of portal vein thrombosis; patients with severe, uncontrolled respiratory disease (asthma, COPD); patients with complete heart block or other significant arrhythmias; those with significant renal disease (CKD stage III or higher); patients who are unable to provide consent; and patients who in the opinion of the principal investigator are not suitable for participation in the trial.