Non-invasive Diagnosis of Portal Hypertension With Acoust... | NCT01644656

Studies
Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)

NCT01644656

Sponsor

VA Connecticut Healthcare System

Status

Completed

Last Update Posted

Sep 6, 2018Actual

Enrollment

500Actual

Phase

Not Applicable

Conditions

Portal Hypertension
Chronic Liver Disease

Interventions

ARFI ultrasound

Countries

United States

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Sep 2018Actual

Completion Date

Sep 2018Actual

First Submitted Date

Jun 19, 2012

First Submission Date that Met QC Criteria

Jul 16, 2012

First Posted Date

Jul 19, 2012Estimated

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

Sep 4, 2018

Last Update Posted Date

Sep 6, 2018Actual

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 aim of this diagnostic study is to evaluate the efficacy of ARFI imaging (a specific type of ultrasound) in assessing the pressure of the portal vein (the major vein passing through the liver) and the amount of liver fibrosis in patients with chronic liver disease.

Detailed Description

DESIGN The study is designed as a prospective, cross-sectional, diagnostic study in which the investigators will evaluate the use of ARFI to diagnose clinically significant portal hypertension (CSPH defined as hepatic veous pressure gradient (HVPG)greater than 10 mmHg), taking HVPG measurements as gold standard.

METHODOLOGY

The study will be performed at the VA Connecticut Healthcare System-West Haven and Yale.
Study population will be recruited among patients from the VA/Yale Liver Clinics or outside hospitals that are referred to VA/Yale for a transjugular liver biopsy and hepatic venous pressure gradient measurement as part of their routine care.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
acoustic radiation force impulse (ARFI)	Experimental	Imaging of liver and spleen using modified ultrasound	Device: ARFI ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARFI ultrasound	Device	ARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures	acoustic radiation force impulse (ARFI)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation of acoustic radiation force impulse (ARFI) measurement of organ stiffness with hepatic venous pressure gradient (HVPG)	Both measurements are estimates of portal hypertension (defined as equal to HVPG greater than 10 mmHg).	Both outcome measurements (ARFI measurements and HVPG) will be obtained within an average time frame of 4-8 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-85 years
compensated chronic liver disease with suspected or confirmed liver cirrhosis sent for transjugular liver biopsy as part of their routine care
signed informed consent

Exclusion Criteria:

known contraindications to the performance of an HVPG measurement or a trans-jugular biopsy
portal thrombosis
previous surgical or transjugular portosystemic shunt
previous total or partial splenectomy
presence of comorbid conditions conferring a life expectancy of less than 1 year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guadalupe Garcia-Tsao, MD	VA Connecticut Healthcare System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale-New Haven Hospital		New Haven	Connecticut	06511	United States
VA Connecticut Healthcare System

Type	Date	Date Unknown
Release	Dec 2, 2019
Reset	Dec 20, 2019

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 2, 2019			Dec 20, 2019

Condition Browse Module

MeSH Terms

ID	Term
D006975	Hypertension, Portal
D005355	Fibrosis
D004194	Disease

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054459	Elasticity Imaging Techniques

Ancestor Terms

ID	Term
D014463	Ultrasonography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided