S-Shearwave Elastography for Assessment of Hepatic Fibrosis

Liver Fibroses Clinical Trial

Official title:

Diagnostic Performance of S-Shearwave Elastography for Hepatic Fibrosis Evaluation: a Multicenter Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047707
• Other study ID #: SNUH-2017-0215
• Status: Completed
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: June 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this multi-center prospective study is to evaluate the diagnostic performance of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of hepatic fibrosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: May 31, 2018
• Est. primary completion date: April 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with chronic liver disease or cirrhosis, or living-donor candidates for liver transplantation, or volunteers

• Signed informed consent

Exclusion Criteria:

• Acute hepatitis or bile duct obstruction

• Serum ALT> 5 times the upper limit of normal within 3 months

• s/p Rt. hemihepatectomy

• s/p liver transplantation

• Large mass or infiltrative lesion in the right lobe of the liver

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibroses

Intervention

Diagnostic Test:
• S-Shearwave and TE
S-Shearwave elastography and Transient elastography (TE) are performed to evaluate hepatic stiffness.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Samsung Medison

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance to detect severe hepatic fibrosis (F3)	Reference standard: histologic diagnosis or Transient elastography	3 months
Secondary	Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes		3 months
Secondary	Intra-observer and inter-observer agreement of S-Shearwave measurements		same day
Secondary	Comparison of diagnostic performance: Shearwave vs. Transient elastography	Reference standard: histologic diagnosis	3 months
Secondary	Usefulness of auto-profile function in S-Shearwave measurements		3 months
Secondary	Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis		3 months