Quantitative Ultrasound for Diagnosing Hepatic Steatosis in Nonalcoholic Fatty Liver Multicenter Study

Diagnoses Disease Clinical Trial

Official title:

Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease: Multicenter Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04985188
• Other study ID #: 2102-159-1199
• Status: Not yet recruiting
• Start date: August 12, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Seoul National University Hospital
• Contact: Jeong Min Lee, MD
• Phone: 02-2072-3107
• Email: jmlshy2000[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the diagnostic performance of quantitative ultrasound parameters for assessing hepatic steatosis in non-alcoholic fatty liver disease using histologic results as reference standard

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinically suspected or proven nonalcoholic fatty liver disease (NAFLD)

• Patients who are scheduled hepatic parenchymal biopsy for suspected liver disease or hepatectomy for living donor liver donation

• aged = 18 years who are willing and able to complete all procedures

Exclusion Criteria:

• excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women)

• clinical, laboratory, or histologic evidence of a liver disease other than NAFLD, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders

• use of steatogenic or hepatotoxic medication

• evidence of decompensated liver disease

• history of liver surgery

• any other condition believed by investigator to affect a patients' compliance, or completion of the study

Related Conditions & MeSH terms

• Diagnoses Disease
• Fatty Liver

Intervention

Diagnostic Test:
• Quantitative ultrasound (QUS) technique
Measurement of quantitative ultrasound parameter using clinical US machine (RS85)

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Seoul National University Hospital	First Affiliated Hospital, Sun Yat-Sen University, Ruijin Hospital, Samsung Medison, Shenzhen Second People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S1)	Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S1)(reference standard: pathologic result)	1 month
Secondary	Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S2 and S3)	Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S2 and S3)(reference standard: pathologic result)	1 month
Secondary	Diagnostic performance of quantitative ultrasound parameters for diagnosing nonalcoholic steatohepatitis (NASH)	Evaluation of area under the ROC curve (AUC) for the detection of nonalcoholic steatohepatitis (reference standard: pathologic result)	1 month