Nonalcoholic Steatohepatitis in Chinese Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Non-Alcoholic Fatty Liver Disease. Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Nonalcoholic Steatohepatitis in Chinese Children: a Long Term Follow-up
Overview
Nonalcoholic steatohepatitis (NASH) is now recognised as an increasing clinical problem in children. Steatosis without significant liver cell injury or fibrosis is the most common form of nonalcoholic fatty liver disease (NAFLD) in both adults and children. Studies in the adult population have variably suggested that steatosis is a benign nonprogressive condition and NASH is recognised as a potentially serious condition with significantly risk of morbidity and mortality. A growing body of evidence suggests that children with NASH frequently show histopathological features that differ from those of adults. The prevalence of this pattern in a wide range of paediatric cases as well as other histopathological lesions and their relevance and prognostic significance in children with NAFLD remains to be determined. Thus the investigators would like to conduct a study of biopsies and clinical information to document the histological features of paediatric NAFLD, to explore the natural history of paediatric NAFLD, and to determine the frequency and prognostic value of these features.
Interventions
- Other No intervention
There will be no specific intervention to these paediatric NASH patient
Primary outcome measures
- Liver related death [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (3)
- Complications of cirrhosis [Time frame: Through study completion, an average of 1 year]
- Liver biopsy [Time frame: Through study completion, an average of 2 year]
- Liver transplant [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- age 1-18 with biopsy-proven NAFLD
- Alcohol consumption less than 20g/day and 10g/day for boys and girls respectively
Exclusion criteria
- with viral hepatitis, e.g. HBV, HCV
- with a1-anti-trypsin disease
- with autoimmune hepatitis
- with Wilson disease
- with liver impaired by drugs
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Children's Liver Disease Center, 302 Hospital — Beijing
Identifiers
NCT: NCT03190538 · H&H_ChildNASH_01