Visceral Stiffness Measurement Using Acoustic Radiation F... | NCT01311934

Studies
Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse

NCT01311934

Sponsor

China Medical University Hospital

Status

Unknown status

Last Update Posted

May 26, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Visceral Stiffness
Liver Fibrosis

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Feb 2012Estimated

Completion Date

Feb 2012Estimated

First Submitted Date

Mar 7, 2011

First Submission Date that Met QC Criteria

Mar 8, 2011

First Posted Date

Mar 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2011

Last Update Posted Date

May 26, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic liver diseases

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sheng-Hung Chen, MD	Contact	886422052121	2264	shcvghtc@gmail.com

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University Hospital	Recruiting	Taichung		40447	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
HBV-infected
HCV-infected