Primary sclerosing cholangitis (PSC) is a rare disease but is increasingly reported in China (mainly in the Chinese language). However, most of the PSC literatures reported from China are case reports, small case series, and review articles. Up to now, there is no information on the epidemiology and disease burden of PSC in China. This study would use EMR/HIS and research databases to investigate the epidemiology, cascade, and treatment pattern of PSC in China.
Identify the PSC cases diagnosed from the earliest date available to the present in the SuValue Research Database and the HIS/EMR from clinical sites through diagnostic ICD codes, laboratory, pathology, imaging, endoscopy, surgery, medication, hospitalization, and health outcomes. Collect information on PSC cases' key demographic, the time of PSC diagnosis, hematological/biochemical variables (ALT, AST, ALP, GGT, ALP TBil, ALB), MRCP or ERCP or pathological report, IBD (UC or CD) symptoms, or colon, medication information, clinical outcomes (including cirrhosis, decompensated cirrhosis, death or liver transplantation) as well as current or past treatment.
Study Type
OBSERVATIONAL
Enrollment
800
This observational study does not have any intervention.
Beijing Friendship Hospital, Capital Medical Univeristy
Beijing, Beijing Municipality, China
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Shanghai Suvalue Health Scientific Ltd.
Shanghai, Shanghai Municipality, China
The prevalence of PSC
The crude prevalence of PSC patients
Time frame: 7 years
Crowd Distribution of PSC in China
Crowd distribution includes the age-specified/sex-specified distribution
Time frame: 7 years
The positive rate of ANCA
The percentage of patients with anti-neutrophil cytoplasmic antibodies (ANCA) positive
Time frame: 0 to 7 years
Dynamic changes of aminotransferase
Dynamic changes of alanine aminotransferase (ALT) from year-0 to year-7
Time frame: 0 to 7 years
Dynamic changes of aspartate aminotransferase
Dynamic changes of aspartate aminotransferase (AST) from year-0 to year-7
Time frame: 0 to 7 years
Dynamic changes of alkaline phosphatase
Dynamic changes of alkaline phosphatase (ALP) from year-0 to year-7
Time frame: 0 to 7 years
Dynamic changes of gamma-glutamyl transpeptidase
Dynamic changes of gamma-glutamyl transpeptidase (GGT) from year-0 to year-7
Time frame: 0 to 7 years
Dynamic changes of serum total bilirubin
Dynamic changes of serum total bilirubin (TBIL) from year-0 to year-7
Time frame: 0 to 7 years
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Dynamic changes of the radiological features measured by Magnetic Resonance Cholangiopancreatography (MRCP) or Encoscopic Retrograde Cholangio-Pancreatography (ERCP)
Dynamic changes of the radiological features at baseline and after 1, 3, 5, 7 years of treatment
Time frame: 0 to 7 years
Incidence of concomitant diseases
Concomitant diseases include IBD (UC or CD), AIH, PBC, cirrhosis, cholelithiasis or cholangiocarcinoma
Time frame: 0 to 7 years
Cumulative incidence of clinical outcomes
Cumulative incidence of liver decompensation (including ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) , liver transplantation, cholangiocarcinoma and death
Time frame: 0 to 7 years
The medication information
Document medication information from year-0 to year-7
Time frame: 0 to 7 years