The Natural History and Prognostic Factors of Compensated Cirrhosis.

Compensated Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03144700
• Other study ID #: ILBS-Cirrhosis-11
• Status: Recruiting
• Start date: January 1, 2010
• Est. completion date: January 2024

Study information

• Verified date: June 2023
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Ankit Bhardwaj, Masters CR
• Phone: 01146300000
• Email: bhardwaj.ankit3[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Compensated Cirrhosis
• Fibrosis
• Liver Cirrhosis

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas		2 years
Secondary	Patients with new onset/progression of esophageal varices during the period of 2 years		2 years
Secondary	Reduction in portal pressure with >20% from baseline at 6 months		6 months
Secondary	Reduction in portal pressure with >20% from baseline at 1 year		1 year
Secondary	Reduction in portal pressure with >20% from baseline at 2 year.		2 year
Secondary	Survival during the period of 2 years.		2 years
Secondary	Number of patients develop hepatocellular carcinoma (HCC) during follow up period 2 years.		2 years
Secondary	Number of patients develop Pulmonary Syndrome (HPS) during follow up period of 2 years.		2 years
Secondary	Number of patients develop Minimal Hepatic Encephalopathy (MHE) during follow up period of 2 years.		2 years
Secondary	Number of patients develop Hypersplenism during follow up period of 2 years.		2 years
Secondary	Number of patients develop Hepatic osteodystrophy during follow up period of 2 years.		2 years