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Status unknownNCT01311934ARFIUpdated May 26, 2011

Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse

An observational study in Visceral Stiffness and Liver Fibrosis, sponsored by China Medical University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-05-26.

Sponsored by China Medical University Hospital · Observational

The sponsor has not verified this record recently (last verified May 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Visceral Stiffness
  • Liver Fibrosis

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03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 200 is above the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with chronic liver diseases

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)

Groups and cohorts

  • HBV-infected
  • HCV-infected
06

Study locations

1 of 1 sites recruiting
  • China Medical University Hospital
    Taichung, 40447, Taiwan
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01311934
Lead sponsor
China Medical University Hospital
First posted
Mar 10, 2011
Start date
Mar 2011
Primary completion
Feb 2012 (estimated)
Completion
Feb 2012 (estimated)
Last update
May 26, 2011

Study contacts

Sheng-Hung Chen, MD
Contact
shcvghtc@gmail.com
886422052121 ext. 2264
Sheng-Hung Chen, MD
principal investigator · Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital
Cheng-Yuan Peng, MD,PhD
study director · Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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