Study Design and Methodology * Study Population:Compensated Cirrhosis * Study Design: An Ambi Prospective Cohort study * Study Period: 2 Years * Sample size: Retrospective- All patients from Jan 2010 to Mar 2017 Prospective- Assuming the incidence of clinical decompensation is 5%/year.With alpha of 5%, power 80% we need to enroll 138 cases. Further assuming 20% drop out 166 cases will be enrolled. * Intervention: This is an observational study. No intervention will be given. Monitoring and assessment: All the routine investigation and clinical information will be collected at 6, 12,18 and 24 months.
Study Type
OBSERVATIONAL
Enrollment
166
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas
Time frame: 2 years
Patients with new onset/progression of esophageal varices during the period of 2 years
Time frame: 2 years
Reduction in portal pressure with >20% from baseline at 6 months
Time frame: 6 months
Reduction in portal pressure with >20% from baseline at 1 year
Time frame: 1 year
Reduction in portal pressure with >20% from baseline at 2 year.
Time frame: 2 year
Survival during the period of 2 years.
Time frame: 2 years
Number of patients develop hepatocellular carcinoma (HCC) during follow up period 2 years.
Time frame: 2 years
Number of patients develop Pulmonary Syndrome (HPS) during follow up period of 2 years.
Time frame: 2 years
Number of patients develop Minimal Hepatic Encephalopathy (MHE) during follow up period of 2 years.
Time frame: 2 years
Number of patients develop Hypersplenism during follow up period of 2 years.
Time frame: 2 years
Number of patients develop Hepatic osteodystrophy during follow up period of 2 years.
Time frame: 2 years
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