Accuracy of RTE for Evaluating Hepatic Fibrosis in Chronic Hepatitis: a Prospective Multicenter Study

Chronic Hepatitis Clinical Trial

Official title:

Accuracy of Real-time Tissue Elastography for Evaluating Hepatic Fibrosis in Chronic Hepatitis: a Prospective Multicenter Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02143180
• Other study ID #: ThirdSunYatSen
• Status: Active, not recruiting
• Phase: N/A
• First received: May 16, 2014
• Last updated: May 16, 2014
• Start date: May 2014

Study information

• Verified date: May 2014
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Our study is a prospective multicenter research and the aim is to explore a variety of suitable evaluation indicators and criteria for diagnosis of diffuse liver fibrosis, to get the corresponding diagnosis threshold, with the domestic common pathological S stages as the gold standard.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1. Patient has a history of chronic hepatitis on clinical diagnosis; 2. Patient undergoed liver biopsy during study time.

Exclusion Criteria:

• 1. Patient cannot receive examination due to critical condition; 2. Patient refuse the examination.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Chronic

Locations

Country	Name	City	State
China	The department of Ultrasound, the third affiliated hospital of Sun Yat-son University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver Fibrosis Index (LFI)		During the examination	No