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

Liver Cirrhosis Clinical Trial

Official title:

Liver and Spleen Stiffness Measured by 2D-shear Wave Elastography for Diagnosis of Liver Fibrosis in Patients With Compensated Advanced Chronic Liver Disease: a Diagnostic Accuracy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06147934
• Other study ID #: ZDWY.GRBK.035
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2023
• Source: Fifth Affiliated Hospital, Sun Yat-Sen University
• Contact: Xi Liu, PhD
• Phone: +86 15992670630
• Email: liuxi26[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Patients with chronic liver disease who visit Fifth Affiliated Hospital, Sun Yat-Sen University will be enrolled from October 2023 to January 2025. Their liver stiffness measured by transient elastography (TE) should be at least 10 kilopascal (kPa) and with no previous decompensation symptoms.

Patients will be asked to sign an informed consent form. After that, researchers will assess the eligibility of the participants according to inclusion and exclusion criteria, and record their demographic data, history of disease, and the etiology of liver disease.

The participants will be required to complete relevant laboratory tests such as blood routine, liver function, kidney function, coagulation function and etiology. After completing the tests, the results will be recorded by primary researchers.

Abdominal ultrasound and 2D-shear wave elastography (2D-SWE) will be conducted 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. Abdominal ultrasound findings, liver stiffness, spleen stiffness, spleen thickness, spleen diameter, portal vein trunk diameter will be recorded by primary researchers.

TE examination will be conducted by experienced nurses, instructing patients to have a fasting period of at least 4 hours prior to the tests. An interval of no more than 1 week should separate the abdominal ultrasound and 2D-SWE examination. The report will be considered highly reliable only if the interquartile range to median ratio (IQR/med) is ≤ 30%, at least 10 successful acquisitions are obtained, and the success rate is at least 60%. Liver stiffness, spleen stiffness and controlled attenuation parameter (CAP) will be recorded by primary researchers.

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. Primary researchers will record the length of specimen, histological stage, etiology of liver disease, immunohistochemistry results and so on.

Demographic characteristics and laboratory results will be collected to describe participants' condition, and the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic (AUROC) of 2D-SWE will be compared with that of TE in diagnosing liver fibrosis, and the cut-off value of 2D-SWE for diagnosing liver fibrosis will be explored.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age=18 years old;

• Chronic liver disease (alcoholic liver disease, chronic hepatitis B, chronic hepatitis C or non-alcoholic fatty liver disease);

• No previous decompensation-related manifestations (such as ascites, gastrointestinal varicose bleeding, hepatic encephalopathy, etc.);

• Informed consent has been signed.

Exclusion Criteria:

• Hepatocellular carcinoma or other advanced malignant tumor;

• Acute liver disease or ALT=5×ULN;

• Persistent substance abuse other than alcohol;

• Pregnancy or HIV infection;

• There are contraindications of percutaneous liver biopsy (such as serious abnormality of coagulation function, etc.);

• There are conditions that seriously affect TE and 2D-SWE measurements (such as the intercostal space is too narrow, BMI=30, etc.);

• Subjects considered unsuitable for including in this study but not included by the above exclusion criteria.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis

Intervention

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.

Locations

Country	Name	City	State
China	The Fifth Affiliated Hospital, Sun Yat-sen University	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of 2D-SWE	True Positive/ (True Positive+False Negative) ×100%	Through study completion, an average of 2 year
Primary	Specificity of 2D-SWE	True Negative/ (True Negative+False Positive) ×100%	Through study completion, an average of 2 year
Primary	Positive Predictive Value of 2D-SWE	True Positive/ (True Positive+False Positive) ×100%	Through study completion, an average of 2 year
Primary	Negative Predictive Value of TE and 2D-SWE	True Negative/ (True Negative+False Negative) ×100%	Through study completion, an average of 2 year
Primary	Overall diagnostic performance of TE and 2D-SWE	Measured by the area under the receiver operating characteristic curve (AUROC). The test accuracy level is considered high when the AUROC value is = 0.9.	Through study completion, an average of 2 year