Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)
1 other identifier
interventional
500
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedFirst Posted
Study publicly available on registry
July 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedSeptember 6, 2018
September 1, 2018
6.2 years
June 19, 2012
September 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
acoustic radiation force impulse (ARFI)
EXPERIMENTALImaging of liver and spleen using modified ultrasound
Interventions
ARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Yale-New Haven Hospital
New Haven, Connecticut, 06511, United States
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guadalupe Garcia-Tsao, MD
VA Connecticut Healthcare System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2012
First Posted
July 19, 2012
Study Start
July 1, 2012
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
September 6, 2018
Record last verified: 2018-09