Chronic Liver Disease
Conditions
Keywords
Postprandial liver and spleen stiffness measurements, Transient elastography, Cirrhosis, Acoustic radiation force impulse
Brief 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 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.
Interventions
DEVICEFibroscan and Acoustic Radiation Force Impulse
Liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse
DEVICEFibroscan
Liver stiffness will be measured before and after a standard meal is administered
DEVICEAcoustic Radiation Force Impulse
Liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse
Sponsors
VA Connecticut Healthcare System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
All the above, the patient, provider and investigator and outcome assessor will not know the result of the biopsy to know if the participant does or does not have cirrhosis at the time of the study
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in liver and spleen stiffness from pre and post meal obtained by Fibroscan | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in liver and spleen stiffness from pre and post meal obtained by ARFI | 30 minutes interval between the two measurements of liver and spleen stiffness from pre meal to post meal | 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 |
Countries
United States
Outcome results
None listed