Primary Biliary Cholangitis (PBC)
Conditions
Brief summary
Several risk assessment scoring systems have been proposed to assess the therapeutic response and predict long term prognosis in ursodeoxycholic acid (UDCA)-treated primary biliary cholangitis (PBC) patients, in order to risk stratify PBC patients and guide their management. However there scoring systems have not been fully validated in Chinese population. This study is going to compare the prognostic ability of these criteria, validate the overseas scoring systems, develop and validate a new scoring system in a cohort of Chinese PBC patients.
Interventions
DRUGUrsodeoxycholic Acid
Standard care of PBC patients
Sponsors
Beijing 302 Hospital
Humanity and Health Research Centre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* With liver biopsy proved PBC
Exclusion criteria
* A positive serological test for hepatitis B or C virus, * Comorbidity of primary sclerosing cholangitis, * Alcoholic liver disease, * Hemochromatosis, * Wilson's disease, * a1-antitrypsin deficiency * Presence of complications of cirrhosis (Total bilirubin \>100 lmol/L, ascites, variceal haemorrhage and hepatic encephalopathy) on admission.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver related Death | During follow-up after a year of starting UDCA, an average of 1 year | Whether the patients die from liver-related causes during the follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications of cirrhosis | During follow-up after a year of starting UDCA, an average of 1 year | Whether the complication of cirrhosis i.e. ascites, hepatic encephalopathy, variceal bleeding occur during the follow-up |
| Liver transplant | During follow-up after a year of starting UDCA, an average of 1 year | Whether the patients have liver transplant during the follow-up |
Countries
China
Outcome results
None listed