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

The Natural History and Prognostic Factors of Compensated Cirrhosis.

Sponsors

Lead sponsor: Institute of Liver and Biliary Sciences, India

Source Institute of Liver and Biliary Sciences, India
Brief 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.

Overall Status Recruiting
Start Date January 1, 2010
Completion Date January 2021
Primary Completion Date January 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas 2 years
Secondary Outcome
Measure Time Frame
Patients with new onset/progression of esophageal varices during the period of 2 years 2 years
Reduction in portal pressure with >20% from baseline at 6 months 6 months
Reduction in portal pressure with >20% from baseline at 1 year 1 year
Reduction in portal pressure with >20% from baseline at 2 year. 2 year
Survival during the period of 2 years. 2 years
Number of patients develop hepatocellular carcinoma (HCC) during follow up period 2 years. 2 years
Number of patients develop Pulmonary Syndrome (HPS) during follow up period of 2 years. 2 years
Number of patients develop Minimal Hepatic Encephalopathy (MHE) during follow up period of 2 years. 2 years
Number of patients develop Hypersplenism during follow up period of 2 years. 2 years
Number of patients develop Hepatic osteodystrophy during follow up period of 2 years. 2 years
Enrollment 166
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Contact

Last name: Dr Ankit Bhardwaj, Masters CR

Phone: 01146300000

Email: [email protected]

Location
facility status Institute of Liver and Biliary Sciences
Location Countries

India

Verification Date

May 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Compensated Cirrhosis

Patient Data No
Study Design Info

Observational model: Other

Time perspective: Other

Source: ClinicalTrials.gov