The Natural History and Prognostic Factors of Compensated Cirrhosis.
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|ClinicalTrials.gov Identifier: NCT03144700|
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : June 14, 2019
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||166 participants|
|Official Title:||The Natural History and Prognostic Factors of Compensated Cirrhosis: An Ambi Prospective Cohort Study|
|Actual Study Start Date :||January 1, 2010|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
- Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas [ Time Frame: 2 years ]
- Patients with new onset/progression of esophageal varices during the period of 2 years [ Time Frame: 2 years ]
- Reduction in portal pressure with >20% from baseline at 6 months [ Time Frame: 6 months ]
- Reduction in portal pressure with >20% from baseline at 1 year [ Time Frame: 1 year ]
- Reduction in portal pressure with >20% from baseline at 2 year. [ Time Frame: 2 year ]
- Survival during the period of 2 years. [ Time Frame: 2 years ]
- Number of patients develop hepatocellular carcinoma (HCC) during follow up period 2 years. [ Time Frame: 2 years ]
- Number of patients develop Pulmonary Syndrome (HPS) during follow up period of 2 years. [ Time Frame: 2 years ]
- Number of patients develop Minimal Hepatic Encephalopathy (MHE) during follow up period of 2 years. [ Time Frame: 2 years ]
- Number of patients develop Hypersplenism during follow up period of 2 years. [ Time Frame: 2 years ]
- Number of patients develop Hepatic osteodystrophy during follow up period of 2 years. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144700
|Contact: Dr Ankit Bhardwaj, Masters CRfirstname.lastname@example.org|
|Institute of Liver and Biliary Sciences||Recruiting|
|New Delhi, Delhi, India, 110070|