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

VA Connecticut Healthcare System22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Chronic Liver Disease

Interventions

Fibroscan and Acoustic Radiation Force ImpulseDEVICE

Liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse

FibroscanDEVICE

Liver stiffness will be measured before and after a standard meal is administered

Acoustic Radiation Force ImpulseDEVICE

Liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Wesy haven va

West Haven, Connecticut, United States

Outcomes

Primary Outcomes

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

Time frame: 30 minutes interval between the two measurements of liver stiffness from pre meal to post meal

Secondary Outcomes

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

Time frame: 30 minutes interval between the two measurements of liver and spleen stiffness from pre meal to post meal

Data from ClinicalTrials.gov

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