PSC Clinical Epidemiology in China

NCT04981756 | Unknown

• 1 other identifier: IN-CN-428-5940
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Primary Sclerosing Cholangitis

Keywords

Epidemiology; Cascade; Treatment

Outcome Measures

Primary Outcomes (2)

• The prevalence of PSC

  The crude prevalence of PSC patients

  7 years

• Crowd Distribution of PSC in China

  Crowd distribution includes the age-specified/sex-specified distribution

  7 years

Secondary Outcomes (10)

• The positive rate of ANCA

  0 to 7 years

• Dynamic changes of aminotransferase

  0 to 7 years

• Dynamic changes of aspartate aminotransferase

  0 to 7 years

• Dynamic changes of alkaline phosphatase

  0 to 7 years

• Dynamic changes of gamma-glutamyl transpeptidase

  0 to 7 years

Interventions

observation OTHER

This observational study does not have any intervention.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Total number of subjects expected to be reviewed is 800. The subjects in this study will consist of two parts: identify PSC cases by retrospective review of an inter-regional database and retro-prospective review of EMR of two tertiary medical centers in Beijing.

You may qualify if:

• Retrospectively review PSC cases before April 1, 2002 will be identified by diagnostic codes from the International Classification of Diseases (ICD)-9, and for those after April 1, 2002, we used ICD-10.
• We identified patients using an electronic search of SuValue Research Database and HIS of 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 keyword search for "primary sclerosing cholangitis" or "seclerosing cholangitis" was conducted on all radiology, endoscopy, pathology reports beginning on earliest date available in the database of SuValue Research Database and HIS of BFH-CMU and BYH-CMU. We reviewed the medical charts of identified patients and diagnostic criteria including cholestatic biochemistry (ALP, GGT elevations), and typical imaging (MRCP or ERCP) or pathological features, excluding other known etiology. For patients with multiple visits for PSC, we reviewed only the index visit. To ensure consistency, chart review was independently assessed by two hepatologists. Discrepancies in compliance were resolved by discussion between the two main reviewers. Any unresolved discrepancies were decided by a third expert hepatologist.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Beijing YouAn Hospital: collaborator
• Shanghai Suvalue Health Scientific Ltd.: collaborator
• The First Hospital of Jilin University: collaborator
• Beijing Ditan Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Second Hospital of Jilin University: collaborator
• Hepatobiliary Disease Hospital of Jilin Province: collaborator
• Lanzhou University Second Hospital: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator

Study Sites (3)

Beijing Friendship Hospital, Capital Medical Univeristy

Beijing, Beijing Municipality, 100050, China

Location

Beijing Youan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100054, China

Location

Shanghai Suvalue Health Scientific Ltd.

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (8)

• Ponsioen CY, Lindor KD, Mehta R, Dimick-Santos L. Design and Endpoints for Clinical Trials in Primary Sclerosing Cholangitis. Hepatology. 2018 Sep;68(3):1174-1188. doi: 10.1002/hep.29882. Epub 2018 Aug 31.

  PMID: 29574971 BACKGROUND

• Deneau M, Jensen MK, Holmen J, Williams MS, Book LS, Guthery SL. Primary sclerosing cholangitis, autoimmune hepatitis, and overlap in Utah children: epidemiology and natural history. Hepatology. 2013 Oct;58(4):1392-400. doi: 10.1002/hep.26454. Epub 2013 Aug 13.

  PMID: 23686586 BACKGROUND

• Boonstra K, Weersma RK, van Erpecum KJ, Rauws EA, Spanier BW, Poen AC, van Nieuwkerk KM, Drenth JP, Witteman BJ, Tuynman HA, Naber AH, Kingma PJ, van Buuren HR, van Hoek B, Vleggaar FP, van Geloven N, Beuers U, Ponsioen CY; EpiPSCPBC Study Group. Population-based epidemiology, malignancy risk, and outcome of primary sclerosing cholangitis. Hepatology. 2013 Dec;58(6):2045-55. doi: 10.1002/hep.26565. Epub 2013 Oct 17.

  PMID: 23775876 BACKGROUND

• Metcalf J, James O. The geoepidemiology of primary biliary cirrhosis. Semin Liver Dis. 1997 Feb;17(1):13-22. doi: 10.1055/s-2007-1007179.

  PMID: 9089907 BACKGROUND

• Liu K, Wang R, Kariyawasam V, Wells M, Strasser SI, McCaughan G, Corte C, Leong RW. Epidemiology and outcomes of primary sclerosing cholangitis with and without inflammatory bowel disease in an Australian cohort. Liver Int. 2017 Mar;37(3):442-448. doi: 10.1111/liv.13328. Epub 2017 Jan 24.

  PMID: 27891750 BACKGROUND

• Shen T, Liu Y, Shang J, Xie Q, Li J, Yan M, Xu J, Niu J, Liu J, Watkins PB, Aithal GP, Andrade RJ, Dou X, Yao L, Lv F, Wang Q, Li Y, Zhou X, Zhang Y, Zong P, Wan B, Zou Z, Yang D, Nie Y, Li D, Wang Y, Han X, Zhuang H, Mao Y, Chen C. Incidence and Etiology of Drug-Induced Liver Injury in Mainland China. Gastroenterology. 2019 Jun;156(8):2230-2241.e11. doi: 10.1053/j.gastro.2019.02.002. Epub 2019 Feb 8.

  PMID: 30742832 BACKGROUND

• Colbaugh R, Glass K, Rudolf C, Tremblay Volv Global Lausanne Switzerland M. Learning to Identify Rare Disease Patients from Electronic Health Records. AMIA Annu Symp Proc. 2018 Dec 5;2018:340-347. eCollection 2018.

  PMID: 30815073 BACKGROUND

• Sada Y, Hou J, Richardson P, El-Serag H, Davila J. Validation of Case Finding Algorithms for Hepatocellular Cancer From Administrative Data and Electronic Health Records Using Natural Language Processing. Med Care. 2016 Feb;54(2):e9-14. doi: 10.1097/MLR.0b013e3182a30373.

  PMID: 23929403 BACKGROUND

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

Observation

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Jidong Jia, MD, PhD

  Beijing Friendship Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Liver Research Center

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 29, 2021
• Study Start: April 7, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Locations

CN (3)