Beta-blockers for Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: An Randomized Controlled Trial (RCT)

Govind Ballabh Pant Hospital

Status: Completed

Conditions: Cirrhosis

Treatments: Drug: Propranolol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00772057

2008-PHT-02

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: No Healthy Volunteers

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
• Failure to give consent to participate in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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164 participants in 2 patient groups, including a placebo group

Propranolol group

Active Comparator group

Treatment:

Drug: Propranolol

Placebo group

Placebo Comparator group

Treatment:

Drug: Placebo