NCT03087344

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: VA Connecticut Healthcare System · Federal
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Liver Disease

Interventions

Type	Name	Description
DEVICE	Fibroscan 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
DEVICE	Fibroscan	Liver stiffness will be measured before and after a standard meal is administered
DEVICE	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

Timeline

• Start date: 2017-10-31
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2017-03-22
• Last updated: 2018-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study