The Natural History and Prognostic Factors of Compensated Cirrhosis.

The Natural History and Prognostic Factors of Compensated Cirrhosis: An Ambi Prospective Cohort Study

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.

Inclusion Criteria:

1. Age 18 to 75 years
2. Compensated cirrhosis
3. Biopsy proven cirrhosis or LSM > 12.5 Kpa.

Exclusion Criteria:

1. Any current or prior clinical decompesnation (ascites, jaundice, encephalopathy or gastrointestinal hemorrhage).
2. Pregnant Women
3. Hepatocellular Carcinoma
4. Known case of severe cardiopulmonary disease
5. Known case of severe Hepato Pulmonary Syndrome