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

NCT06147934 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-11-28

No results posted yet for this study

Summary

A observational diagnostic study will be conducted to evaluate the performance of liver stiffness and spleen stiffness measured by 2D-shear wave elastography (2D-SWE) for diagnosing liver fibrosis in people with compensated Advanced Chronic Liver Disease (cACLD), and explore the cut-off value of 2D-SWE for diagnosing liver fibrosis.

Conditions

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.

Sponsors & Collaborators

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Xi Liu, PhD · The Fifth Affiliated Hospital, Sun Yat-sen University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06147934 on ClinicalTrials.gov