Status:
COMPLETED
Beta-blockers for Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: An Randomized Controlled Trial (RCT)
Lead Sponsor:
Govind Ballabh Pant Hospital
Conditions:
Cirrhosis
Eligibility:
All Genders
12-80 years
Phase:
NA
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 con...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00772057
Start Date
October 1 2004
End Date
October 1 2008
Last Update
December 21 2009
Active Locations (1)
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1
Department of Gastroenterology, G B Pant Hospital
New Delhi, National Capital Territory of Delhi, India, 110002