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

Not Applicable

Completed

• Conditions: Chronic Liver Disease

• Registration Number: NCT03087344
• Lead Sponsor: VA Connecticut Healthcare System

Brief 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.

Study Timeline

• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-22
• Study Start: 2017-10-31
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in liver and spleen stiffness from pre and post meal obtained by Fibroscan	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 Outcome Measures

Name	Time	Method
Change in liver and spleen stiffness from pre and post meal obtained by ARFI	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

Trial Locations

Locations (1)

Wesy haven va; 🇺🇸 West Haven, Connecticut, United States