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Status unknownNCT01268865ARFIUpdated Jun 3, 2011

Acoustic Radiation Force Impulse (ARFI)Technology in Prediction of Liver Fibrosis

An observational study in 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 2011-06-03.

Sponsored by China Medical University Hospital · Observational

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has not verified this record recently (last verified Jun 2011), so the status shown — last known as Recruiting — may be out of date.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

Study summary

Background: In patients with chronic liver diseases, liver fibrosis staging is crucial for hazard evaluation of future disease complication development and thus for the optimal decision making on treatment selections.In the era of antiviral and antifibrotic treatments, clinical and research demands are also increasing for non-invasive surveillance of liver fibrosis to evaluate the progression or regression. However, local baseline data on liver stiffness measurement (LSM) using ARFI technique is still lacking in Taiwan, where viral hepatitides are highly endemic. Aim: Using the ARFI elastosonography, we are dedicated to the aims to recruit patients based on strict but appropriate criteria, to complete the correlation and validity studies between ARFI quantification and the referenced METAVIR fibrosis scoring and to conduct subsequent innovative studies on liver diseases. Materials and Methods: We plan to perform the ARFI quantification for each HBV or HCV-infected patient immediately followed by priorly scheduled conventional liver biopsy for METAVIR scoring during the same session of examination. Statistics: The first year's study using ARFI will focus on the correlation testings and validity studies using receiver operating characteristics.

Read the detailed description

Contribution and Future Works: Using the ARFI quantification either as a causal factor or as a outcome, we can conduct future analyses ranging from validations, regressions to prospective time-to-event analysis among our cohorts.

02

Conditions studied

  • Liver Fibrosis

Keywords

  • Acoustic Radiation Force Impulse (ARFI)
  • Virtual Touch Quantification (VTQ)
  • liver stiffness measurement (LSM)
  • liver fibrosis
  • cirrhosis
  • hepatitis B
  • hepatitis C
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.

04

Who can participate

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

Study population

HBV or HCV-infected patients about to undergo liver biopsy to assist in clinical decision making

Inclusion criteria

  • infected with HBV only or HCV only

Exclusion criteria

Exclusion Criteria:

  • concurrent HBV-HCV infection, etc.
05

Study design

Observational model
Cohort
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 Jun 3, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01268865
Lead sponsor
China Medical University Hospital
First posted
Dec 31, 2010
Start date
Dec 2010
Last update
Jun 3, 2011

Study contacts

Sheng-Hung Chen, MD
Contact
shcvghtc@gmail.com
886-4-22052121 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
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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