Early Primary Prophylaxis With Beta-Blockers In Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: A Randomized Controlled Trial

Govind Ballabh Pant Hospital1 site in 1 country164 target enrollmentOctober 2004

ConditionsCirrhosis

InterventionsPropranolol Placebo

DrugsPropranolol Placebo

Overview

Phase: Not Applicable
Intervention: Propranolol
Conditions: Cirrhosis
Sponsor: Govind Ballabh Pant Hospital
Enrollment: 164
Locations: 1
Primary Endpoint: The primary endpoint of the study was the development of large (>5 mm) esophageal varices (grade 3 or 4 by Conn's classification)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Background and Aims: The efficacy of portal pressure reduction by beta blockers for the management of small (≤5 mm) esophageal varices in patients of cirrhosis is not clear. The present randomized controlled trial aims to address these issues. The investigators also assessed the utility of serial HVPG measurements in these patients.

Patients and Methods: Consecutive patients with cirrhosis with small varices, with no history of variceal bleed, were randomized to receive propranolol or placebo. These patients were further randomized to undergo no HVPG, only baseline HVPG, or serial HVPG measurement. Propranolol was titrated to reduce heart-rate to 55/min.

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

October 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Govind Ballabh Pant Hospital

Eligibility Criteria

Inclusion Criteria

•A clinical, radiological or histologic diagnosis of cirrhosis was made
•Age was between 18 and 70 years
•Esophageal varices were small (i.e. ≤5 mm or of grade 1 or 2 according to Conn et al).

Exclusion Criteria

•Presence of previous variceal bleeding
•Previous medical, surgical or endoscopic treatment for portal hypertension
•Child-Pugh score \>13
•Neoplastic disease of any site
•Splenic or portal vein thrombosis
•Concurrent illnesses expected to decrease life expectancy to less than one year
•Pregnancy
•Contraindication to beta-blockers (atrioventricular block, sinus bradycardia with heart rate \<50 beats per minute, arterial hypotension with systolic blood pressure \<90 mm Hg, heart failure, asthma, peripheral arterial disease, or diabetes needing insulin treatment)
•Concurrent anti-viral treatment during the study period
•Inability to perform follow-up

Arms & Interventions

Propranolol group

Intervention: Propranolol

Placebo group

Intervention: Placebo

Outcomes

Primary Outcomes

The primary endpoint of the study was the development of large (>5 mm) esophageal varices (grade 3 or 4 by Conn's classification)

Time Frame: 24 months

Secondary Outcomes

Secondary endpoints were variceal bleeding, death, adverse effects of beta blockers, and hemodynamic response to beta-blocker in patients who underwent serial HVPG(24 months)