ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B

Liver Fibrosis Clinical Trial

Official title:

Evaluation of ShearWave™ Elastography Performances for the Non-Invasive Assessment of Liver Fibrosis in Chinese Patients With Chronic Hepatitis B Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313649
• Other study ID #: LE2
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: April 18, 2016
• Start date: December 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: SuperSonic Imagine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard). The population that will be evaluated are Chinese patients infected with the Hepatitis B virus.

Description:

Hepatitis B is becoming increasingly common. The liver becomes stiffer and this is called fibrosis. A non-invasive method to accurately stage fibrosis is necessary in order to begin the correct treatment. Currently, liver biopsy is used to do this, but there are many disadvantages with this technique.

ShearWave Elastography (SWE), available on the ultrasound machine Aixplorer®, is a non-invasive method to evaluate liver fibrosis.

This study will evaluate how liver stiffness measurements made with SWE correspond with a biopsy result (currently the gold standard).

The sensitivity, specificity, positive predictive value and negative predictive value of liver stiffness measurements with Aixplorer to evaluate the different stages of fibrosis will be analyzed.

Liver stiffness measurement made by the Aixplorer will also be compared to blood markers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing a liver ultrasound exam due to confirmed Hepatitis B infection ,

• Patients having reached the age of majority in China,

• Patients with a liver biopsy for histological evaluation of liver fibrosis, performed within 3 months after the SWE measurement date, and having the recommended quality criterion:

• minimal length of biopsy samples of 15 mm, stored in paraffin

• Minimal number of portal tracts of 6 per biopsy samples

• Patients of Chinese ethnic origin

Exclusion Criteria:

• Any patient presenting with combined etiologies of chronic liver diseases, including non-Hepatitis B viral infection(Hepatitis A, C, D, E, chronic alcoholic liver disease, hemochromatosis, autoimmune hepatitis, etc)

• History of antiviral therapy at any time

• Any patient presenting with a co-infection of HIV

• Any patient presenting with combined liver malignant tumor

• Previous liver transplantation

• Pregnant women

• Any patient with combined hepatic congestive condition such as Budd Chiari Syndrome, congestive heart failure, chronic constrictive pericarditis…

• Any patient combined with intrahepatic cholestasis

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis B, Chronic
• Liver Cirrhosis
• Liver Fibrosis

Locations

Country	Name	City	State
China	People's Liberation Army General(301)Hospital	Beijing
China	West China Hospital, Sichuan University	Chengdu
China	1st Affiliated Hospital, Sun Yat-Sen University	GuangZhou
China	3rd Affiliated Hospital, Sun Yat-Sen University	Guangzhou
China	GuangZhou 8th People's Hospital	GuangZhou
China	1st Affiliated Hospital, Haerbin Medical University	Haerbin
China	1st Affiliated Hospital, ZheJiang University	HangZhou
China	YunNan Province Second People's Hospital	KunMing
China	2nd Affiliated Hospital, Lanzhou University	LanZhou
China	Jiangsu Provincial Hospital	NanJing
China	Shanghai 1st People's Hospital	Shanghai
China	Shengjing Hospital of Chinese Medical University	ShenYang
China	1st Affiliated Hospital, XiAn Transportation University	XiAn
China	Xijing Hospital	XiAn
China	Isolation Hospital, HeNan Province	ZhengZhou

Sponsors (1)

Lead Sponsor	Collaborator
SuperSonic Imagine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Areas under the ROC curves for the ability of SWE measurements to predict at least significant fibrosis (Metavir F=2), at least severe fibrosis (Metavir F=3), and liver cirrhosis (Metavir F=4).	This will be determined by histological examination of liver biopsy	Within 12 months of the study start date	No
Secondary	Sensitivity, specificity, positive and negative predictive values of SWE to predict at least significant fibrosis (Metavir F=2), at least severe fibrosis (Metavir F=3), and liver cirrhosis (Metavir F=4).	This will be determined by histological examination of liver biopsy	Within 12 months of the study start date	No