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