The Natural History and Prognostic Factors of Compensated Cirrhosis.

Institute of Liver and Biliary Sciences, India

Status: Enrolling

Conditions: Compensated Cirrhosis

Study type: Observational

Funder types: Other

Identifiers

NCT03144700

ILBS-Cirrhosis-11

Details and patient eligibility

About

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.

Enrollment: 166 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

166 participants in 1 patient group

Compensated Cirrhosis