Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 9/7/2018 |
Start Date: | October 31, 2017 |
End Date: | June 30, 2018 |
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.
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.
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.
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
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