Multicenter Observational Study of PSC and IgG4-SC in China

Shanghai Jiao Tong University

Status: Enrolling

Conditions: IgG4-related Sclerosing Cholangitis; Primary Sclerosing Cholangitis

Treatments: Other: Only observation

Study type: Observational

Funder types: Other

Identifiers

NCT05463445

SC2022CH001

Details and patient eligibility

About

The investigators aimed to collect demographic features and clinical outcomes in patients diagnosed with PSC and IgG4-SC by utilizing participants database from multiple medical centers across Mainland China. Cross-sectional studies will focus on characterizing clinical presentations and validating diagnostic and prognostic models on Chinese PSC and IgG4-SC patients.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age above 18 years old,
• Male or Female,
• Patients admitted in our medical centers which met the PSC criteria according to The European Association for the Study of the Liver Clinical Practice Guidelines "Management of cholestatic liver diseases" in 2009; or patients diagnosed with IgG4-SC which met initially using the Japan Pancreas Society criteria and confirmed using HISORt criteria.

Exclusion criteria

• Female subjects who is pregnant, breastfeeding or is considering being pregnant during the study;
• History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system;
• History of infectious diseases, including hepatis A, B, C, E and tuberculosis.

Trial design

1,000 participants in 2 patient groups

A

Description:

patients diagnosed with Primary Sclerosing Cholangitis which met the PSC criteria according to The European Association for the Study of the Liver Clinical Practice Guidelines "Management of cholestatic liver diseases" in 2009.

Treatment:

Other: Only observation

B

Description:

patients diagnosed with IgG4-related Sclerosing Cholangitis which met initially using the Japan Pancreas Society criteria and confirmed using HISORt criteria.

Treatment:

Other: Only observation