The Natural History and Prognostic Factors of Compensated Cirrhosis.
NCT ID: NCT03144700
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
166 participants
OBSERVATIONAL
2010-01-01
2024-01-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Compensated Cirrhosis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Compensated cirrhosis
3. Biopsy proven cirrhosis or LSM \> 12.5 Kpa.
Exclusion Criteria
2. Pregnant Women
3. Hepatocellular Carcinoma
4. Known case of severe cardiopulmonary disease
5. Known case of severe Hepato Pulmonary Syndrome
18 Years
75 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Other Identifiers
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ILBS-Cirrhosis-11
Identifier Type: -
Identifier Source: org_study_id
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