NCT03144700

The Natural History and Prognostic Factors of Compensated Cirrhosis.

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 166 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Compensated Cirrhosis

Timeline

• Start date: 2010-01-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2017-05-09
• Last updated: 2023-06-22

Locations

1 site across 1 country: India