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

NCT06147934 | Unknown

• 1 other identifier: ZDWY.GRBK.035
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Fibrosis; Liver Cirrhosis

Keywords

2D-SWE; Liver Cirrhosis; Liver Fibrosis; Liver Stiffness; Spleen Stiffness

Outcome Measures

Primary Outcomes (5)

• Sensitivity of 2D-SWE

  True Positive/ (True Positive+False Negative) ×100%

  Through study completion, an average of 2 year

• Specificity of 2D-SWE

  True Negative/ (True Negative+False Positive) ×100%

  Through study completion, an average of 2 year

• Positive Predictive Value of 2D-SWE

  True Positive/ (True Positive+False Positive) ×100%

  Through study completion, an average of 2 year

• Negative Predictive Value of TE and 2D-SWE

  True Negative/ (True Negative+False Negative) ×100%

  Through study completion, an average of 2 year

• 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

Study Arms (1)

study group

All participants included will be in one study group.

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

Interventions

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

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.

study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.);

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The Fifth Affiliated Hospital, Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xi Liu, PhD

  The Fifth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi Liu, PhD

CONTACT

+86 15992670630; liuxi26@mail.sysu.edu.cn

Chenyue Jin, BMed

CONTACT

+86 18025084237; jinchy5@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 28, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)