Clinical trial NCT03087344: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Liver Disease
Keywords: Postprandial liver and spleen stiffness measurements
Transient elastography
Cirrhosis
Acoustic radiation force impulse
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2017-03-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Change in liver and spleen stiffness from pre and post meal obtained by Fibroscan
timeFrame: 30 minutes interval between the two measurements of liver stiffness from pre meal to post meal
Secondary outcomes:
measure: Change in liver and spleen stiffness from pre and post meal obtained by ARFI
timeFrame: 30 minutes interval between the two measurements of liver and spleen stiffness from pre meal to post meal
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Wesy haven va
state: Connecticut
Study officials:
affiliation: Yale and VA
name: Guadalupe Garcia-Tsao, MD
role: PRINCIPAL_INVESTIGATOR
References: