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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibroscan and Acoustic Radiation Force Impulse | Device | Liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 minutes interval between the two measurements of liver stiffness from pre meal to post meal |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guadalupe Garcia-Tsao, MD | Yale and VA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wesy haven va | West Haven | Connecticut | 06516 | United States |
once all data is collected, possibly share individual data
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 2, 2019 | |
| Reset | Dec 16, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 2, 2019 | Dec 16, 2019 |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054459 | Elasticity Imaging Techniques |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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
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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
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| Fibroscan | Device | Liver stiffness will be measured before and after a standard meal is administered |
|
|
| Acoustic Radiation Force Impulse | Device | Liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse |
|
| 30 minutes interval between the two measurements of liver and spleen stiffness from pre meal to post meal |