NCT01311934

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

May 26, 2011

Status Verified

May 1, 2011

Enrollment Period

11 months

First QC Date

March 7, 2011

Last Update Submit

May 24, 2011

Conditions

Visceral StiffnessLiver Fibrosis

Study Arms (2)

HBV-infected

HCV-infected

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic liver diseases

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sheng-Hung Chen, MD

    Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

    PRINCIPAL INVESTIGATOR

  • Cheng-Yuan Peng, MD,PhD

    Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

    STUDY DIRECTOR

Central Study Contacts

Sheng-Hung Chen, MD

CONTACT

886422052121shcvghtc@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 10, 2011

Study Start

March 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

May 26, 2011

Record last verified: 2011-05

Locations

TW(1)