The Natural History and Prognostic Factors of Compensated Cirrhosis.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Compensated Cirrhosis

• Study Type: Observational
• Enrollment (Estimated): 166

Contacts and Locations

• Study Contact: Name: Dr Ankit Bhardwaj, Masters CR; Phone Number: 01146300000; Email: bhardwaj.ankit3@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Compensated Cirrhosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Compensated Cirrhosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 17, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ILBS-Cirrhosis-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No