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Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status and phase

Terminated
Phase 3

Conditions

Esophageal Varices

Treatments

Procedure: endoscopic variceal band ligation

Study type

Interventional

Funder types

Other

Identifiers

NCT00409084
HM10546

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • cirrhosis
  • medium to large varices

Exclusion criteria

  • contraindications to beta blockers
  • refusal to give consent
  • prior history of variceal hemorrhage
  • creatinine > 1.5 mg/dl

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2 participants in 2 patient groups

1
Active Comparator group
Description:
endoscopic variceal band ligation
Treatment:
Procedure: endoscopic variceal band ligation
2
Active Comparator group
Description:
subjects will receive nadolol (beta blocker) at 20mg/day with dose titration
Treatment:
Procedure: endoscopic variceal band ligation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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