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Completed

NCT Number: NCT03047707

S-Shearwave Elastography for Assessment of Hepatic Fibrosis

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.

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Key information

Conditions

Liver Fibroses Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S-Shearwave and TE

Diagnostic Test

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

Primary outcomes

  1. Diagnostic performance to detect severe hepatic fibrosis (F3)

    Time frame: 3 months

    Reference standard: histologic diagnosis or Transient elastography

Secondary outcomes

  1. Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes

    Time frame: 3 months

  2. Intra-observer and inter-observer agreement of S-Shearwave measurements

    Time frame: same day

  3. Comparison of diagnostic performance: Shearwave vs. Transient elastography

    Time frame: 3 months

    Reference standard: histologic diagnosis

  4. Usefulness of auto-profile function in S-Shearwave measurements

    Time frame: 3 months

  5. Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Samsung Medison

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2017
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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