Clinical trial NCT06147934: Liver and Spleen Stiffness Measured by 2D-SWE for Diagnosis of Liver Fibrosis in Patients With cACLD
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Fibrosis
Liver Cirrhosis
Keywords: 2D-SWE
Liver Cirrhosis
Liver Fibrosis
Liver Stiffness
Spleen Stiffness
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 10kPa no previous decompensation symptoms.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of 2D-SWE
timeFrame: Through study completion, an average of 2 year
measure: Specificity of 2D-SWE
timeFrame: Through study completion, an average of 2 year
measure: Positive Predictive Value of 2D-SWE
timeFrame: Through study completion, an average of 2 year
measure: Negative Predictive Value of TE and 2D-SWE
timeFrame: Through study completion, an average of 2 year
measure: Overall diagnostic performance of TE and 2D-SWE
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Fifth Affiliated Hospital, Sun Yat-sen University
name: Xi Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: