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OpenTrials
Completed

NCT Number: NCT03087344

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wesy haven va

West Haven, Connecticut, 06516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

FibroScan

Device

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

Other names: Transient elastography

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

Primary outcomes

  1. Change in liver and spleen stiffness from pre and post meal obtained by Fibroscan

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

    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

Secondary outcomes

  1. Change in liver and spleen stiffness from pre and post meal obtained by ARFI

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

    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

Sponsors and collaborators

Lead sponsor

VA Connecticut Healthcare System

Fed

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2017
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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