Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse

NCT ID: NCT01311934

Last Updated: 2011-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Visceral Stiffness Liver Fibrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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HBV-infected

No interventions assigned to this group

HCV-infected

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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China Medical University Hospital

Principal Investigators

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Sheng-Hung Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

Cheng-Yuan Peng, MD,PhD

Role: STUDY_DIRECTOR

Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sheng-Hung Chen, MD

Role: CONTACT

886422052121 ext. 2264

Facility Contacts

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Sheng-Hung Chen, MD

Role: primary

886422052121 ext. 2264

Other Identifiers

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DMR100-IRB-001

Identifier Type: -

Identifier Source: org_study_id

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