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NCT02335073 Clinical Trial

Effect of 4 Liver Fibrosis Tests (PIIINP, CIV, LN, and HA) on the Prognosis of Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:
Effect of 4 Liver Fibrosis Tests (PIIINP, CIV, LN, and HA) on the Prognosis of Liver Cirrhosis: A Single-center, Prospective, Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02335073
Other study ID # LFT4-LC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2015
Est. completion date June 2016

Study information
Verified date February 2024
Source General Hospital of Shenyang Military Region
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Liver biopsy is the reference method for the measurement of liver fibrosis. But it has many limitations, such as sampling error and individual variation in interpreting the results. Currently, serum liver fibrosis markers have been employed as non-invasive diagnosis of liver fibrosis and evaluation of the severity of liver fibrosis. They include laminin (LN), hyaluronic acid (HA), collagen type IV (CIV), and N-terminal propeptide of collagen III (PIIINP). However, few study was conducted to explore the role of these liver fibrosis markers in evaluating the prognosis of liver cirrhosis. Our hypothesis is that LN, HA, CIV, and PIIINP in combination or alone can predict the prognosis of liver cirrhosis.

Recruitment information / eligibility
Status Completed
Enrollment 108
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Patients were admitted to our department. 2. Patients were diagnosed with liver cirrhosis. 3. Patients signed the informed consent and agreed to test serum liver fibrosis markers (PIIINP, CIV, LN, and HA). Exclusion Criteria: 1. Non-cirrhotic patients. 2. Malignancy. 3. Severe cardiopulmonary diseases. 4. Severe infectious diseases. 5. Other diseases with a shortened lifespan. 6. Pregnant and breastfeeding. 7. Poor adherence.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Venous blood

Locations
Country Name City State
China Department of Gastroenterology, General Hospital of Shenyang Military Area Shenyang Liaoning

Sponsors (1)
Lead Sponsor Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Death 6-12 months
Secondary Hepatic decompensation events 6-12 months
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