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

NCT03087344 | Completed DMC FDA Device

• 1 other identifier: 0042
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease

Keywords

Postprandial liver and spleen stiffness measurements; Transient elastography; Cirrhosis; Acoustic radiation force impulse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Chronic liver disease

EXPERIMENTAL

patient who will undergo liver biopsy will undergo 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 and Acoustic Radiation Force Impulse; Device: Fibroscan; Device: Acoustic Radiation Force Impulse

Interventions

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

Chronic liver disease

Fibroscan DEVICE

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

Also known as: Transient elastography

Chronic liver disease

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

Chronic liver disease

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Connecticut Healthcare System: lead

Study Sites (1)

Wesy haven va

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Guadalupe Garcia-Tsao, MD

  Yale and VA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All the above, the patient, provider and investigator and outcome assessor will not know the result of the biopsy to know if the participant does or does not have cirrhosis at the time of the study
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Cross sectional diagnostic study of Chronic liver disease patients who have had a liver stiffness measurement performed that is discordant with clinical impression either clinically the patient appears to have cirrhosis but liver stiffness measurement is less than 10 kPa or clinically there is no evidence of cirrhosis but there liver stiffness measurement is more than 15 kPa or the patients liver stiffness measurement is in the grey zone which means patients' liver stiffness measurement is between 10 and 15 kPa to investigate the utility of postprandial postprandial liver and spleen stiffness measurements in the noninvasive diagnosis of cirrhosis

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 22, 2017
• Study Start: October 31, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

US (1)