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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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.
- 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:
- The cases with secondary sclerosing cholangitis caused by cholelithiasis, IgG4 relateddisease, malignancy or other known etiologies.
- 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
Connect with a study center
Beijing Friendship Hospital, Capital Medical Univeristy
Beijing, Beijing 100050
ChinaSite Not Available
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing 100054
ChinaSite Not Available
Shanghai Suvalue Health Scientific Ltd.
Shanghai, Shanghai 200032
ChinaSite Not Available

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