Chronic Liver DiseaseNCT03087344
Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis
A study testing Fibroscan and Acoustic Radiation Force Impulse, Fibroscan and Acoustic Radiation Force Impulse in people with Chronic Liver Disease, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
This is a study that will evaluate the utility of measuring liver and spleen stiffness before and after a meal by a non invasive ultrasound based technologies called Fibroscan (Transient elastography) and acoustic radio-frequency impulse (ARFI) in diagnosing or excluding cirrhosis in patients with chronic liver… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- Fibroscan and Acoustic Radiation Force Impulse, Fibroscan and Acoustic Radiation Force Impulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2017to 30 Jun 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
- History of chronic liver disease who have had a liver stiffness measurement performed that is discordant with clinical impression (clinically the patient appears to have cirrhosis but LSM <10) or clinically there is no evidence of cirrhosis but LSM>15) or LSM are in the grey zone (LSM between 10 and 15 kPa)
Who cannot join
- Any signs of decompensated cirrhosis (e.g., jaundice, ascites, variceal hemorrhage, or hepatic encephalopathy)
- Hepatocellular carcinoma
- Patients with chronic Hep C who have undergone antiviral therapy
- Ongoing alcohol abuse
- Acute hepatitis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
This is a study that will evaluate the utility of measuring liver and spleen stiffness before and after a meal by a non invasive ultrasound based technologies called Fibroscan (Transient elastography) and acoustic radio-frequency impulse (ARFI) in diagnosing or excluding cirrhosis in patients with chronic liver disease who will be getting a liver biopsy.
Read the detailed description
This is a prospective longitudinal study that will evaluate the utility of change in liver stiffness (LSM) and spleen stiffness measurements after a test meal in patients whom the diagnosis cannot be reliably ruled in or ruled out based on two measurement of LSM by TE per standard of care. This includes patients in whom there is discordance between clinical impression and LSM and/or LSM are in the grey zone (LSM between 10 and 15 kPa). Liver biopsy/HVPG which is performed as standard of care will be used as gold standard.
- Conditions
- Chronic Liver Disease
- Being tested
- Fibroscan and Acoustic Radiation Force Impulse, Fibroscan, Acoustic Radiation Force Impulse
- Keywords
- Postprandial liver and spleen stiffness measurements, Transient elastography, Cirrhosis, Acoustic radiation force impulse
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibroscan and Acoustic Radiation Force ImpulseDevice
Liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse
FibroscanDevice
Also called Transient elastography
Liver stiffness will be measured before and after a standard meal is administered
Acoustic Radiation Force ImpulseDevice
Liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse
| Study group | Role | What they receive |
|---|---|---|
| Chronic liver disease | Experimental | patient who will undergo liver biopsy will undergo liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse Receives: Device: Fibroscan and Acoustic Radiation Force Impulse; Device: Fibroscan; Device: Acoustic Radiation Force Impulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver and spleen stiffness from pre and post meal obtained by Fibroscan
Liver stiffness will be obtained by fibroscan in kPa, Liver stiffness will be obtained pre and post meal, the delta change of liver stiffness will be computed in an AUROC to see the Sensitivity, specificity, positive predictive value and negative predictive value of the delta change and diagnosing or excluding cirrhosis
Measured: 30 minutes interval between the two measurements of liver stiffness from pre meal to post meal
Secondary outcomes (1)
Change in liver and spleen stiffness from pre and post meal obtained by ARFI
Liver and spleen stiffness will be obtained by ARFI in m/sec, Liver and spleen stiffness will be obtained pre and post meal, the delta change of liver and spleen stiffness will be computed in an AUROC to see the Sensitivity, specificity, positive predictive value and negative predictive value of the delta change and diagnosing or excluding cirrhosis
Measured: 30 minutes interval between the two measurements of liver and spleen stiffness from pre meal to post meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start31 Oct 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies 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
- Model description
- Cross sectional diagnostic study of Chronic liver disease patients who have had a liver stiffness measurement performed that is discordant with clinical impression either clinically the patient appears to have cirrhosis but liver stiffness measurement is less than 10 kPa or clinically there is no evidence of cirrhosis but there liver stiffness measurement is more than 15 kPa or the patients liver stiffness measurement is in the grey zone which means patients' liver stiffness measurement is between 10 and 15 kPa to investigate the utility of postprandial postprandial liver and spleen stiffness measurements in the noninvasive diagnosis of cirrhosis
- Masking
- None (open label)
- Enrolment
- 22 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, Yale and VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087344
- Sponsor's protocol ID
- 0042
- Status last verified
- Sep 2018
- First submitted
- 6 Mar 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: once all data is collected, possibly share individual data
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis
- ClinicalTrials.gov ID
- NCT03087344
- Acronym / sponsor ID
- 0042
- Conditions
- Chronic Liver Disease
- Keywords
- Postprandial liver and spleen stiffness measurements, Transient elastography, Cirrhosis, Acoustic radiation force impulse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 22 Mar 2017 (actual)
- 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.
This is a study that will evaluate the utility of measuring liver and spleen stiffness before and after a meal by a non invasive ultrasound based technologies called Fibroscan (Transient elastography) and acoustic radio-frequency impulse (ARFI) in diagnosing or excluding cirrhosis in patients with chronic liver disease who will be getting a liver biopsy.
Detailed description
This is a prospective longitudinal study that will evaluate the utility of change in liver stiffness (LSM) and spleen stiffness measurements after a test meal in patients whom the diagnosis cannot be reliably ruled in or ruled out based on two measurement of LSM by TE per standard of care. This includes patients in whom there is discordance between clinical impression and LSM and/or LSM are in the grey zone (LSM between 10 and 15 kPa). Liver biopsy/HVPG which is performed as standard of care will be used as gold standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross sectional diagnostic study of Chronic liver disease patients who have had a liver stiffness measurement performed that is discordant with clinical impression either clinically the patient appears to have cirrhosis but liver stiffness measurement is less than 10 kPa or clinically there is no evidence of cirrhosis but there liver stiffness measurement is more than 15 kPa or the patients liver stiffness measurement is in the grey zone which means patients' liver stiffness measurement is between 10 and 15 kPa to investigate the utility of postprandial postprandial liver and spleen stiffness measurements in the noninvasive diagnosis of cirrhosis
| Arm | Type | Receives |
|---|---|---|
| Chronic liver disease | Experimental | Device: Fibroscan and Acoustic Radiation Force Impulse, Device: Fibroscan, Device: Acoustic Radiation Force Impulsepatient who will undergo liver biopsy will undergo liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-85
- History of chronic liver disease who have had a liver stiffness measurement performed that is discordant with clinical impression (clinically the patient appears to have cirrhosis but LSM <10) or clinically there is no evidence of cirrhosis but LSM>15) or LSM are in the grey zone (LSM between 10 and 15 kPa)
Key exclusion criteria (6 listed)
- Any signs of decompensated cirrhosis (e.g., jaundice, ascites, variceal hemorrhage, or hepatic encephalopathy)
- Hepatocellular carcinoma
- Patients with chronic Hep C who have undergone antiviral therapy
- Ongoing alcohol abuse
- Acute hepatitis
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 |
|---|---|---|
| Fibroscan and Acoustic Radiation Force ImpulseLiver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse | Device | Chronic liver disease |
| FibroscanAlso: Transient elastographyLiver stiffness will be measured before and after a standard meal is administered | Device | Chronic liver disease |
| Acoustic Radiation Force ImpulseLiver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse | Device | Chronic liver disease |
Primary outcome
Change in liver and spleen stiffness from pre and post meal obtained by Fibroscan
Time frame: 30 minutes interval between the two measurements of liver stiffness from pre meal to post meal
Liver stiffness will be obtained by fibroscan in kPa, Liver stiffness will be obtained pre and post meal, the delta change of liver stiffness will be computed in an AUROC to see the Sensitivity, specificity, positive predictive value and negative predictive value of the delta change and diagnosing or excluding cirrhosis
1 secondary outcome
Change in liver and spleen stiffness from pre and post meal obtained by ARFI
Time frame: 30 minutes interval between the two measurements of liver and spleen stiffness from pre meal to post meal
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 5 Sep 2018.
- Individual participant dataSharing planned: Undecided. once all data is collected, possibly share individual data
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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
Yale and VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibroscan and Acoustic Radiation Force Impulse, Fibroscan and Acoustic Radiation Force Impulse in people with Chronic Liver Disease, run by VA Connecticut Healthcare System at 1 site 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 2 inclusion and 6 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 5 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 1 site 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?
Change in liver and spleen stiffness from pre and post meal obtained by Fibroscan (time frame: 30 minutes interval between the two measurements of liver stiffness from pre meal to post meal). 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 5 Sep 2018.