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Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse (ARFI)

C

China Medical University

Status

Unknown

Conditions

Liver Fibrosis
Visceral Stiffness

Study type

Observational

Funder types

Other

Identifiers

NCT01311934
DMR100-IRB-001

Details and patient eligibility

About

The acoustic radiation force impulse (ARFI) technology provides real-time measurements of tissue stiffness.

Aim: Using the ARFI ultrasonography, the investigators aims are to complete the correlation and validity studies between visceral ARFI quantification and the referenced Metavir fibrosis scoring and to conduct subsequent innovative studies on liver diseases.

Full description

Using ARFI technology, we are establishing a complete hepatic and visceral shear wave spectrum to correspond to the entire METAVIR fibrosis scoring and various functional stratifications.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • patients with chronic liver diseases who underwent liver biopsy
  • patients with pathologically or radiologically proven cirrhosis

Exclusion criteria

  • Post major abdominal surgery
  • After interferon or neucleos(t)ides treatment
  • PBC,PSC,WD,AIH,viral coinfections
  • Liver abscess
  • Exposure to hepatotoxic drugs or chemicals
  • Thrombosis of splenic vein, portal veins
  • After resection or embolism of the spleen
  • Acute or chronic pancreatitis
  • Biopsy contraindications (not exclusive)
  • ARFI measurements low quality
  • Fibrotest contraindications:

Acute hepatitides, Extrahepatic cholestasis, e.g., pancreatic cancer, gallstones, CBD>0.7cm Severe hemolysis

  • Cardiac congestion
  • Liver cancer other than HCC
  • Treated HCC

Trial design

200 participants in 2 patient groups

HBV-infected
HCV-infected

Trial contacts and locations

1

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Central trial contact

Sheng-Hung Chen, MD

Data sourced from clinicaltrials.gov

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