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CompletedNCT02917408Updated Nov 10, 2020

Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital

An observational study in Cholangitis, Liver Cirrhosis, Biliary and Cholestasis, sponsored by Xiaoli Fan. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-10.

Sponsored by Xiaoli Fan · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
769
Ages
18 Years and older
Sex
All
01

Study summary

Retrospective study of all patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records. The following variables will be retrospectively studied: age, sex, first symptoms, clinical characteristics, pathology, treatment, stage, complications of cirrhosis, other autoimmune diseases and long-term outcome.

02

Conditions studied

  • Cholangitis
  • Liver Cirrhosis, Biliary
  • Cholestasis
  • Liver Diseases
  • Liver Cirrhosis
  • Bile Duct Diseases
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 769 is above the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Xiaoli Fan is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records.

Inclusion criteria

  • Newly diagnosis of PBC at West China Hospital during January 2001 to July 2016.

Exclusion criteria

Exclusion Criteria:

  • Simultaneously diagnosed of autoimmune hepatitis or primary sclerosing cholangitis.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
769 participants (actual)
Patient registry
No

Groups and cohorts

  • Primary biliary cholangitis during January 2001 to July 2016
06

What researchers measure

Primary outcomes

  1. Description of demographics, management patterns (clinical and diagnostic), comorbidities of PBC patients at diagnosis during the past 16 years.

    Time frame: Up to 16 years.

Secondary outcomes

  1. Evaluation of adverse outcome free survival of the PBC cohort during the 16 years.

    Time frame: Up to 16 years.

07

Study locations

1 site
  • West China Hospital
    Chengdu, Sichuan, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02917408
Lead sponsor
Xiaoli Fan
Responsible party
Xiaoli Fan (Principal Investigator, West China Hospital) — Sponsor-investigator
First posted
Sep 28, 2016
Start date
Sep 2016
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Nov 10, 2020

Study contacts

Li Yang, MD
study chair · West China Hospital,Chengdu, Sichuan, China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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