Clinical trial NCT04012242: Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study
Official title: Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study for Patients With Nonalcoholic Steatohepatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nonalcoholic Steatohepatitis
Ultrasound
Elastography
Keywords: Nonalcoholic Steatohepatitis
Ultrasound
Elastography
Dispersion
Lead sponsor: Tokyo Medical University
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Nonalcoholic fatty liver disease (NAFLD) patients who are scheduled for liver biopsy for the differential diagnosis of NASH and/or NAFLD patients who are scheduled for the MR elastography (MRE) and MRI-proton density fat friction (MRI-PDFF).

Brief summary: The objective of this study is: (1) to investigate the correlation of ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, Liver / Kidney Intensity Ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and steatosis); (2) to evaluate the diagnostic performance of SW speed for liver fibrosis, Dispersion slope for intralobular inflammation and Attenuation value for steatosis by comparison with the tissue diagnosis by liver biopsy.


Eligibility criteria: Inclusion Criteria:

* Nonalcoholic fatty liver disease (NAFLD) patients who are scheduled for liver biopsy for the differential diagnosis of NASH and/or NAFLD patients who are scheduled for the MR elastography (MRE) and MRI-proton density fat friction (MRI-PDFF).
* Without a history of alcohol use, which lead to alcoholic hepatic involvement (pure alcohol below 30 g/day for male, 20 g/day for female).

Exclusion Criteria:

* Patients with endocrine disorder (hypopituitarism, growth hormone deficiency, hyperthyroidism etc.), serious nutrition disorder, and drug-induced hepatic involvement (steroid, tamoxifen, valproic acid, amiodarone etc.), which may lead to the steatosis
* Hepatitis B, Hepatitis C and HIV patients
* Primary biliary cholangitis, Primary sclerosing cholangitis, and Autoimmune hepatitis patients
* Wilson's disease, α1-antitrypsin deficiency, and hemochromatosis patients
* Malignant liver tumor, common bile duct stone, and jaundice patients
* Patients after jejunoileal bypass surgery or massive intestinal resection surgery
* Patients whose treatment changes during the period between imaging examination and liver biopsy, including medications such as antidiabetic drugs and other treatments which may change the fat deposition or inflammation of liver.

Primary outcomes:
measure: Diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23)
timeFrame: At the time of examination
Secondary outcomes:
measure: Correlation between ultrasound parameters and the pathological parameters
timeFrame: At the time of examination
measure: Diagnostic performance of SW speed for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4).
timeFrame: At the time of examination
measure: Diagnostic performance of Normalized Local Variance for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4)
timeFrame: At the time of examination
measure: Diagnostic performance of Normalized Local Variance for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3)
timeFrame: At the time of examination
measure: Diagnostic performance of Dispersion slope for intralobular inflammation (A0 vs. A123, and A012 vs. A3)
timeFrame: At the time of examination
measure: Diagnostic performance of Attenuation value for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3)
timeFrame: At the time of examination
measure: Diagnostic performance of Liver/Kidney Intensity Ratio for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3)
timeFrame: At the time of examination
measure: Diagnostic performance of the computer aided algorithm for NASH
timeFrame: At the time of examination
measure: Diagnostic performance of MRI-PDFF for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3).
timeFrame: At the time of examination
measure: Diagnostic performance of CAP for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3).
timeFrame: At the time of examination
measure: Diagnostic performance of MRE for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4).
timeFrame: At the time of examination
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Parker
country: United States
facility: Rocky Vista University
state: Colorado
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Boardman
country: United States
facility: The Surgical Hospital at Southwoods
state: Ohio
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Guangzhou
country: China
facility: SunYatSen University First Hospital
city: Guangzhou
country: China
facility: SunYatSen University Third Hospital
city: Hangzhou
country: China
facility: Zhejiang University No. 2 Hospital
city: Paris
country: France
facility: University Paris Nord
city: Erlangen
country: Germany
facility: University of Erlangen
city: Leipzig
country: Germany
facility: University of Leipzig
city: Pavia
country: Italy
facility: University of Pavia
city: Rome
country: Italy
facility: Policlinico Umberto I, Univ. La Sapienza
city: Hyogo
country: Japan
facility: Hyogo Medical University
city: Kurume
country: Japan
facility: Kurume University
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital / Imperial College London
Study officials:
affiliation: Tokyo Medical University
name: Katsutoshi Sugimoto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: