Incidence & Predictive Factors of Recompensation in Children With Decompensated Cirrhosis as Per the Baveno VII Criteria

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial is focusing on understanding how often and under what conditions children with a serious liver condition called decompensated cirrhosis can improve or "recompensate" after treatment. Decompensated cirrhosis means the liver is severely damaged, leading to symptoms like fluid buildup in the abdomen, confusion, and bleeding from swollen veins. The researchers want to identify factors that might help predict which children are more likely to see improvements in their liver function after treating the underlying causes of their cirrhosis.

To participate in this study, children under 18 years old who have been diagnosed with decompensated cirrhosis may be eligible. They must show specific signs of liver damage and have an underlying cause that can be treated, such as certain liver infections or diseases. Throughout the trial, participants will receive treatment for their condition, and the team will monitor their progress over time. Importantly, the study aims to find new ways to measure liver health, which could help doctors better understand and treat children with this serious illness in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. \< 18 years of age at presentation
• • 2. Decompensated cirrhosis at baseline
• • 1. Cirrhosis:defined asliver histology findings (\> F4 fibrosis as per Ishak system), and/or
• • 2. radiological findings of an irregular nodular liver with/out left/caudate liver enlargement
• • 3. Decompensation:defined as presence of ascites (any grade), and/orHE (overt), and/or variceal haemorrhage (endoscopy proven)
• • 3. Fulfilling Recompensation criteria as per Baveno VII (2022) after treatment initiation
• • 4. 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)
• • 5. 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.
• • 6. 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:
• • 1. refused consent
• • 2. patients with liver cancer or other active malignancy
• • 3. Any significant extrahepatic disease