Status:
UNKNOWN
Liver and Spleen Stiffness Measured by TE and 2D-SWE for Diagnosis of CSPH in Patients With cACLD
Lead Sponsor:
Fifth Affiliated Hospital, Sun Yat-Sen University
Conditions:
Liver Cirrhosis
Liver Fibrosis
Eligibility:
All Genders
18+ years
Brief Summary
A observational diagnostic study will be conducted to compare the performance of liver stiffness and spleen stiffness measured by 2D-shear wave elastography (2D-SWE) and transient elastography (TE) fo...
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 elastogr...
Eligibility Criteria
Inclusion
- Age≥18 years old;
- Chronic liver disease (alcoholic liver disease, chronic hepatitis B, chronic hepatitis C or non-alcoholic fatty liver disease);
- Liver stiffness ≥10kPa measured by transient elastography (TE);
- No previous decompensation-related manifestations (such as ascites, gastrointestinal varicose bleeding, hepatic encephalopathy, etc.);
- Informed consent has been signed.
Exclusion
- There are contraindications of hepatic venous pressure gradient (HVPG) measurement (such as severe abnormal coagulation function;
- Non-cirrhosis portal hypertension;
- Hepatocellular carcinoma or other advanced malignant tumor;
- Acute liver disease or ALT≥5×ULN;
- A history of splenectomy or splenic embolism;
- Acute or chronic thrombosis of the portal vein;
- Pregnancy or HIV infection;
- A history of using non-selective beta blockers (NSBB) or diuretic in the last 3 months;
- Persistent substance abuse other than alcohol;
- A history of transjugular intrahepatic portosystemic shunts (TIPs), endoscopic variceal ligation(EVL) , hardener or tissue gel therapy;
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06147947
Start Date
December 1 2023
End Date
January 1 2025
Last Update
November 28 2023
Active Locations (1)
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1
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, Guangdong, China, 519000