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Study on the influencing factors of fatigue in patients with primary biliary cholangitis

Study on influencing factors of fatigue in patients with primary biliary cholangitis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082861
Enrollment
Unknown
Registered
2024-04-10
Start date
2024-04-15
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary biliary cholangitis

Interventions

Fatigue group/No fatigue group:None

Sponsors

Beijing You'an Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: The diagnostic criteria for PBC are in line with the diagnostic guidance recommendations for PBC in the 2021 "Diagnosis and Treatment Guidelines for Primary Biliary Cholangitis (2021)" of the Hepatology Branch of the Chinese Medical Association. Diagnostic points: (1) Mainly among middle-aged women, the main clinical manifestations are fatigue, itchy skin, jaundice, osteoporosis and fat-soluble vitamin deficiency, which may be accompanied by a variety of autoimmune diseases, but there are also many patients with no obvious clinical symptoms. symptom. (2) Biochemical examination: The most common increase in ALP and GGT is: ALT and AST can increase slightly, usually 2-4 times the upper limit of normal values. (3) Immunological examination: The increase in immunoglobulins is mainly IgM. A positive AMA is the most diagnostic laboratory test. There are nine types of AMA, of which type 2 (M2) is the most specific. (4) Imaging examination: All patients with cholestasis should undergo ultrasound examination of the hepatobiliary system. In patients with a normal bile duct system and a positive AMA on ultrasound, PBC can be diagnosed without bile duct imaging. (5) Liver tissue biopsy: For patients who are AMA-positive and have typical clinical manifestations and biochemical abnormalities, liver tissue biopsy is not necessary for diagnosis.

Exclusion criteria

Exclusion criteria: (1) Combined with chronic HBV, HCV, CMV, EBV infection or hepatitis or cirrhosis caused by alcohol, drugs and other causes; (2) Liver failure; (3) Combined with primary liver cancer or liver metastasis; (4) Combined with fatty liver or severe cardiac insufficiency or organic kidney disease; (5) Pregnant women.

Design outcomes

Primary

MeasureTime frame
PBC Fatigue Scale;

Countries

China

Contacts

Public ContactYing Han

Beijing You'an Hospital, Capital Medical University

gladyshanying@163.com+86 135 2080 9804

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026