Multicenter Observational Study of PSC and IgG4-SC in China

• Conditions: Primary Sclerosing Cholangitis; IgG4-related Sclerosing Cholangitis
• Interventions: Other: Only observation

• Registration Number: NCT05463445
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-01
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-18
• Last Update Submitted: 2022-07-18
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-12-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Only observation	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.
B	Only observation	patients diagnosed with IgG4-related Sclerosing Cholangitis which met initially using the Japan Pancreas Society criteria and confirmed using HISORt criteria.

Primary Outcome Measures

Name	Time	Method
The percentage of new occurrence of decompensated liver related events, malignancies, liver transplantation and liver-related death caused by PSC and IgG4-SC	1 year	describe the characteristics and clinical outcomes of PSC and IgG4-SC patients among multiple medical centers in China

Trial Locations

Locations (1)

RenJi Hospital; 🇨🇳 Shanghai, 上海市, China