Portal HypertensionNCT01644656
Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)
A study testing ARFI ultrasound in people with Portal Hypertension and Chronic Liver Disease, run by VA Connecticut Healthcare System at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Portal Hypertension, Chronic Liver Disease
- What is being tested?
- ARFI ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale-New Haven Hospital
New Haven, Connecticut, 06511
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Non-invasive Diagnosis of Portal Hypertension by Acoustic Radiation Force Impulse (ARFI) Imaging of the Liver and Spleen in Patients With Chronic Liver Disease
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.
Read the 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.
- Conditions
- Portal Hypertension, Chronic Liver Disease
- Being tested
- ARFI ultrasound
- Keywords
- portal hypertension, cirrhosis, ARFI, diagnostic study
- Medical subject headings
- Hypertension, Portal, Fibrosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARFI ultrasoundDevice
Also called acoustic radiation force impulse
ARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures
| Study group | Role | What they receive |
|---|---|---|
| acoustic radiation force impulse (ARFI) | Experimental | Imaging of liver and spleen using modified ultrasound Receives: Device: ARFI ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Both outcome measurements (ARFI measurements and HVPG) will be obtained within an average time frame of 4-8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Guadalupe Garcia-Tsao, MD, Principal investigator, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644656
- Sponsor's protocol ID
- 01582
- Status last verified
- Sep 2018
- First submitted
- 19 Jun 2012
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Diagnosis of Portal Hypertension by Acoustic Radiation Force Impulse (ARFI) Imaging of the Liver and Spleen in Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT01644656
- Acronym / sponsor ID
- 01582
- Conditions
- Portal Hypertension, Chronic Liver Disease
- Keywords
- portal hypertension, cirrhosis, ARFI, diagnostic study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Jul 2012
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acoustic radiation force impulse (ARFI) | Experimental | Device: ARFI ultrasoundImaging of liver and spleen using modified ultrasound |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARFI ultrasoundAlso: acoustic radiation force impulseARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures | Device | acoustic radiation force impulse (ARFI) |
Primary outcome
correlation of acoustic radiation force impulse (ARFI) measurement of organ stiffness with hepatic venous pressure gradient (HVPG)
Time frame: Both outcome measurements (ARFI measurements and HVPG) will be obtained within an average time frame of 4-8 hours
Both measurements are estimates of portal hypertension (defined as equal to HVPG greater than 10 mmHg).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guadalupe Garcia-Tsao, MD principal investigator
VA Connecticut Healthcare System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARFI ultrasound in people with Portal Hypertension and Chronic Liver Disease, run by VA Connecticut Healthcare System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of acoustic radiation force impulse (ARFI) measurement of organ stiffness with hepatic venous pressure gradient (HVPG) (time frame: Both outcome measurements (ARFI measurements and HVPG) will be obtained within an average time frame of 4-8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.