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Cirrhosis is a leading cause of morbidity and mortality world- wide and can develop on the basis of repetitive and/or chronic liver injury due to toxic, infectious, metabolic and genetic pathogenic factors. Traditionally, the natural history of cirrhosis has often been considered a one-way street, with a definite and irreversible progression from a compensated to a decompensated disease stage. But recent data has shown that if the underlying etiology can be successfully treated, cirrhosis can regress and recompensation of liver disease can occur. Hence, in this study we want to evaluate the incidence and predictive factors of recompensation in pediatric subjects with decompensated cirrhosis as per the Baveno VII criteria. We would also evaluate the predictive factors of recompensation in pediatric decompensated chronic liver disase (DCLD) subjects and would explore systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in pediatric subjects with decompensated cirrhosis.
Aim- To evaluate the incidence and predictive factors of recompensation in pediatric subjects with decompensated cirrhosis as per the Baveno VII criteria Primary objective: To determine the incidence of recompensation in pediatric subjects with decompensated cirrhosis as per Baveno VII criteria
Secondary objectives:
Intervention: None, since it is an observational study only
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decompensated Cirrhosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other | Other | It is an observational study. Subjects will receive the treatment as per institute protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the incidence of recompensation in pediatric subjects with decompensated cirrhosis as per Baveno VII criteria | 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the predictive factors of recompensation in pediatric DCLD subjects | 1.5 years | |
| To investigate the systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in in pediatric subjects with decompensated cirrhosis. |
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Inclusion Criteria:
< 18 years of age at presentation
Decompensated cirrhosis at baseline
Fulfilling Recompensation criteria as per Baveno VII (2022) after treatment initiation
Sustained cure, suppression or removal of the underlying aetiology of cirrhosis
a. Includes treatable etiologies like Hepatitis B, Autoimmune liver disease, Wilson disease, Budd Chiari syndrome, MLDs (like Galactosemia, Tyrosinemia, Bile acid synthetic defects)
Resolution of ascites and hepatic encephalopathy (HE) after discontinuation of diuretics and prophylactic therapies, as well as the absence of variceal bleeding for 12 months.
Sustained improvement of biochemical liver function, as as- sessed by serum albumin, bilirubin and INR (international normalized ratio) a. improvement in liver function parameters to values within normal ranges (albumin >35 g/L & INR < 1.5 & bilirubin < 2 mg/dl)
Exclusion Criteria:
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Subjects visiting to ILBS with decompensated Chronic liver disease from Aug 2023 till April 2025.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Anmol Anmol, MD | Contact | 01146300000 | dranmol1991@gmail.com | |
| Dr Vikrant Sood, DM | Contact | 011-46300000 | drvickyster@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| 1.5 years |
| To assess incidence of re-decompensation in patients with recompensation. | 2 years |