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

Chronic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087344
• Other study ID #: 0042
• Status: Completed
• Phase: N/A
• Start date: October 31, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: September 2018
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Fibrosis
• Liver Cirrhosis
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Wesy haven va	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 minutes interval between the two measurements of liver stiffness from pre meal to post meal
Secondary	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	30 minutes interval between the two measurements of liver and spleen stiffness from pre meal to post meal