Multicenter Study of Clinical Characteristics and Management of Primary Sclerosing Cholangitis and IgG4-related Sclerosing Cholangitis in China.

RenJi Hospital1 site in 1 country1,000 target enrollmentJuly 1, 2022

ConditionsPrimary Sclerosing Cholangitis IgG4-related Sclerosing Cholangitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Primary Sclerosing Cholangitis
Sponsor: RenJi Hospital
Enrollment: 1000
Locations: 1
Primary Endpoint: The percentage of new occurrence of decompensated liver related events, malignancies, liver transplantation and liver-related death caused by PSC and IgG4-SC
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2022

End Date

July 31, 2023

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

RenJi Hospital

Responsible Party

Principal Investigator

ma xiong

Principal Investigator

RenJi Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The percentage of new occurrence of decompensated liver related events, malignancies, liver transplantation and liver-related death caused by PSC and IgG4-SC

Time Frame: 1 year

describe the characteristics and clinical outcomes of PSC and IgG4-SC patients among multiple medical centers in China