PSC Clinical Epidemiology in China

Primary Sclerosing Cholangitis Clinical Trial

Official title:

Primary Sclerosing Cholangitis in China: Epidemiology, Cascade and Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04981756
• Other study ID #: IN-CN-428-5940
• Status: Active, not recruiting
• Start date: April 7, 2021
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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.

Exclusion Criteria:

1. The cases with secondary sclerosing cholangitis caused by cholelithiasis, IgG4 related disease, 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.

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis

Intervention

Other:
• observation
This observational study does not have any intervention.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical Univeristy	Beijing	Beijing
China	Beijing Youan Hospital, Capital Medical University	Beijing	Beijing
China	Shanghai Suvalue Health Scientific Ltd.	Shanghai	Shanghai

Sponsors (11)

Lead Sponsor

Collaborator

Beijing Friendship Hospital

Beijing Ditan Hospital, Beijing YouAn Hospital, First Affiliated Hospital of Jilin University, First Affiliated Hospital of Xinjiang Medical University, Hepatobiliary Disease Hospital of Jilin Province, Lanzhou university second hospital, Shanghai Suvalue Health Scientific Ltd., The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second Norman Bethune Hospital of Jilin University, Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of PSC	The crude prevalence of PSC patients	7 years
Primary	Crowd Distribution of PSC in China	Crowd distribution includes the age-specified/sex-specified distribution	7 years
Secondary	The positive rate of ANCA	The percentage of patients with anti-neutrophil cytoplasmic antibodies (ANCA) positive	0 to 7 years
Secondary	Dynamic changes of aminotransferase	Dynamic changes of alanine aminotransferase (ALT) from year-0 to year-7	0 to 7 years
Secondary	Dynamic changes of aspartate aminotransferase	Dynamic changes of aspartate aminotransferase (AST) from year-0 to year-7	0 to 7 years
Secondary	Dynamic changes of alkaline phosphatase	Dynamic changes of alkaline phosphatase (ALP) from year-0 to year-7	0 to 7 years
Secondary	Dynamic changes of gamma-glutamyl transpeptidase	Dynamic changes of gamma-glutamyl transpeptidase (GGT) from year-0 to year-7	0 to 7 years
Secondary	Dynamic changes of serum total bilirubin	Dynamic changes of serum total bilirubin (TBIL) from year-0 to year-7	0 to 7 years
Secondary	Dynamic changes of the radiological features measured by Magnetic Resonance Cholangiopancreatography (MRCP) or Encoscopic Retrograde Cholangio-Pancreatography (ERCP)	Dynamic changes of the radiological features at baseline and after 1, 3, 5, 7 years of treatment	0 to 7 years
Secondary	Incidence of concomitant diseases	Concomitant diseases include IBD (UC or CD), AIH, PBC, cirrhosis, cholelithiasis or cholangiocarcinoma	0 to 7 years
Secondary	Cumulative incidence of clinical outcomes	Cumulative incidence of liver decompensation (including ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) , liver transplantation, cholangiocarcinoma and death	0 to 7 years
Secondary	The medication information	Document medication information from year-0 to year-7	0 to 7 years