Liver and Spleen Stiffness Measured by 2D-SWE for Diagnosis of Liver Fibrosis in Patients With cACLD

RecruitingOBSERVATIONAL
Enrollment

150

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

January 1, 2025

Study Completion Date

January 1, 2025

Conditions
Liver FibrosisLiver Cirrhosis
Interventions
DIAGNOSTIC_TEST

Diagnostic Test: Transient elastography (TE) and 2D-shear wave elastography (2D-SWE)

"Index test: TE examination will be completed by experienced nurses, requiring fasting for more than 4 hours before the examination and an interval of no more than 1 week from the abdominal ultrasound and 2D-SWE examination. The report will be considered highly reliable only if IQR/med is ≤ 30%, at least 10 successful acquisitions are obtained, and the success rate is at least 60%. Abdominal ultrasound and 2D-shear wave elastography (2D-SWE) will be completed by a sonographer, the interval between ultrasonic examination and laboratory tests should be less than a week, and the patients should fast for at least 4 hours before the examination.~Reference standard: Liver biopsy will be conducted by experienced interventionists and reported by pathologists. There should be a maximum interval of no more than 1 month between the liver biopsy and ultrasound examination, and the length of specimen should be more than 1.0cm."

Trial Locations (1)

519000

RECRUITING

The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai

All Listed Sponsors
lead

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER