Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis

VA Connecticut Healthcare System

Status: Completed

Conditions: Chronic Liver Disease

Treatments: Device: Acoustic Radiation Force Impulse; Device: Fibroscan and Acoustic Radiation Force Impulse; Device: Fibroscan

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03087344

0042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Chronic liver disease

Experimental group

Description:

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

Treatment:

Device: Fibroscan

Device: Acoustic Radiation Force Impulse

Device: Fibroscan and Acoustic Radiation Force Impulse