The Natural History and Prognostic Factors of Compensated Cirrhosis.

Recruiting

• Conditions: Compensated Cirrhosis

• Registration Number: NCT03144700
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-09
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-17
• Last Update Posted: 2023-06-22
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas	2 years

Secondary Outcome Measures

Name	Time	Method
Survival during the period of 2 years.	2 years
Number of patients develop Minimal Hepatic Encephalopathy (MHE) during follow up period of 2 years.	2 years
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 1 year	1 year
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 Hypersplenism during follow up period of 2 years.	2 years
Reduction in portal pressure with >20% from baseline at 6 months	6 months
Number of patients develop Hepatic osteodystrophy during follow up period of 2 years.	2 years
Reduction in portal pressure with >20% from baseline at 2 year.	2 year

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India