The Natural History and Prognostic Factors of Compensated Cirrhosis.

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03144700

Enrollment

166

Registered

2017-05-09

Start date

2010-01-01

Completion date

2024-01-31

Last updated

2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compensated Cirrhosis

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Patients with new onset/progression of esophageal varices during the period of 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
Number of patients develop hepatocellular carcinoma (HCC) during follow up period 2 years.	2 years

Countries

India

Contacts

Primary ContactDr Ankit Bhardwaj, Masters CR

bhardwaj.ankit3@gmail.com01146300000

Outcome results