PSC Clinical Epidemiology in China

Last updated: May 25, 2023
Sponsor: Beijing Friendship Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Primary Biliary Cholangitis

Liver Disease

Liver Disorders

Treatment

observation

Clinical Study ID

NCT04981756
IN-CN-428-5940
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Retrospectively review PSC cases before April 1, 2002 will be identified by diagnosticcodes from the International Classification of Diseases (ICD)-9, and for those afterApril 1, 2002, we used ICD-10.
  2. We identified patients using an electronic search of SuValue Research Database and HISof BFH-CMU and BYH-CMU using PSC related ICD codes (ICD-9: 576.1; ICD-10:K83.016/K83.016(China version)). To supplement the ICD search, an electronic keywordsearch for "primary sclerosing cholangitis" or "seclerosing cholangitis" was conductedon all radiology, endoscopy, pathology reports beginning on earliest date available inthe database of SuValue Research Database and HIS of BFH-CMU and BYH-CMU. We reviewedthe medical charts of identified patients and diagnostic criteria includingcholestatic biochemistry (ALP, GGT elevations), and typical imaging (MRCP or ERCP) orpathological features, excluding other known etiology. For patients with multiplevisits for PSC, we reviewed only the index visit. To ensure consistency, chart reviewwas independently assessed by two hepatologists. Discrepancies in compliance wereresolved by discussion between the two main reviewers. Any unresolved discrepancieswere decided by a third expert hepatologist.

Exclusion

Exclusion Criteria:

  1. The cases with secondary sclerosing cholangitis caused by cholelithiasis, IgG4 relateddisease, malignancy or other known etiologies.
  2. The cases with missing key results on clinical, biochemical (ALP, GGT, bilirubin),radiological (MRCP or ERCP) or histological investigations.

Study Design

Total Participants: 800
Treatment Group(s): 1
Primary Treatment: observation
Phase:
Study Start date:
April 07, 2021
Estimated Completion Date:
December 31, 2023

Study Description

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.

Connect with a study center

  • Beijing Friendship Hospital, Capital Medical Univeristy

    Beijing, Beijing 100050
    China

    Site Not Available

  • Beijing Youan Hospital, Capital Medical University

    Beijing, Beijing 100054
    China

    Site Not Available

  • Shanghai Suvalue Health Scientific Ltd.

    Shanghai, Shanghai 200032
    China

    Site Not Available

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