Beta-blockers for Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: An Randomized Controlled Trial (RCT)
- Registration Number
- NCT00772057
- Lead Sponsor
- Govind Ballabh Pant Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo group Placebo - Propranolol group Propranolol -
- Primary Outcome Measures
Name Time Method The primary endpoint of the study was the development of large (>5 mm) esophageal varices (grade 3 or 4 by Conn's classification) 24 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Department of Gastroenterology, G B Pant Hospital
🇮🇳New Delhi, Delhi, India