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

Primary Purpose

Chronic Liver Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fibroscan and Acoustic Radiation Force Impulse
Fibroscan
Acoustic Radiation Force Impulse
Sponsored by
VA Connecticut Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Liver Disease focused on measuring Postprandial liver and spleen stiffness measurements, Transient elastography, Cirrhosis, Acoustic radiation force impulse

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wesy haven va

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chronic liver disease

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2017
Last Updated
September 4, 2018
Sponsor
VA Connecticut Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT03087344
Brief Title
Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis
Official Title
Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Connecticut Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease
Keywords
Postprandial liver and spleen stiffness measurements, Transient elastography, Cirrhosis, Acoustic radiation force impulse

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Masking Description
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
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic liver disease
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Fibroscan and Acoustic Radiation Force Impulse
Intervention Description
Liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse
Intervention Type
Device
Intervention Name(s)
Fibroscan
Other Intervention Name(s)
Transient elastography
Intervention Description
Liver stiffness will be measured before and after a standard meal is administered
Intervention Type
Device
Intervention Name(s)
Acoustic Radiation Force Impulse
Intervention Description
Liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse
Primary Outcome Measure Information:
Title
Change in liver and spleen stiffness from pre and post meal obtained by Fibroscan
Description
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 Outcome Measure Information:
Title
Change in liver and spleen stiffness from pre and post meal obtained by ARFI
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guadalupe Garcia-Tsao, MD
Organizational Affiliation
Yale and VA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wesy haven va
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
once all data is collected, possibly share individual data

Learn more about this trial

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

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