Two-dimensional Shear Wave Elastography for Assessment of Cirrhosis and Portal Hypertension

NCT06358092 | Not Yet Recruiting

• 1 other identifier: ZSSYXHNK2401
• Study Type: observational
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

Exploring and establishing new non-invasive risk stratification techniques for portal hypertension based on E imaging technology for measuring liver and spleen stiffness is an urgent need in this field of research.

Conditions

Cirrhosis, Liver; Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• the diagnostic performance of liver and spleen stiffness by E imaging technology for clinically significant portal hypertension

  Using HVPG as the gold standard, the diagnostic performance of measuring liver and spleen stiffness based on E imaging technology for clinically significant portal hypertension.

  1 year

Secondary Outcomes (2)

• the diagnostic performance of microvessel imaging of hepatic microcirculation by E imaging technology for clinically significant portal hypertension

  1 year

• the difference among left, middle and right hepatic venous pressure gradient

  1 year

Study Arms (2)

Training cohort

To explore the cut-off value of LSM and SSM by 2D-SWE for assessment of CSPH in cirrhosis.

Diagnostic Test: Hepatic venous pressure gradient; Diagnostic Test: Two-Dimensional Shear Wave Elastography

Validation cohort

To validate the cut-off value of LSM and SSM by 2D-SWE for assessment of CSPH in cirrhosis.

Diagnostic Test: Hepatic venous pressure gradient; Diagnostic Test: Two-Dimensional Shear Wave Elastography

Interventions

Hepatic venous pressure gradient DIAGNOSTIC_TEST

HVPG is a measurement used to assess portal hypertension, a condition characterized by increased blood pressure in the portal vein, which carries blood from the digestive organs to the liver. HVPG measurement involves inserting a catheter into the hepatic vein via jugular vein puncture to directly measure the pressure within the liver. By comparing the pressure in the hepatic vein with that in the portal vein, HVPG provides valuable information about the severity of portal hypertension and helps in predicting clinical outcomes in patients with liver cirrhosis and related conditions. HVPG measurements are crucial in guiding treatment decisions, assessing treatment response, and predicting the risk of complications such as variceal bleeding and liver failure.

Training cohort; Validation cohort

Two-Dimensional Shear Wave Elastography DIAGNOSTIC_TEST

2D-SWE is a non-invasive imaging technique used to assess tissue stiffness, particularly in the liver. This technology utilizes ultrasound to generate shear waves within the tissue being examined. By measuring the speed of these shear waves as they propagate through the tissue, 2D-SWE can provide quantitative information about tissue elasticity or stiffness. In the context of liver disease, including cirrhosis and fibrosis, 2D-SWE is valuable for evaluating the degree of liver stiffness, which correlates with the severity of liver fibrosis. This information aids in diagnosis, staging, and monitoring of liver diseases, allowing for early detection of complications and assessment of treatment response. Compared to traditional biopsy-based methods, 2D-SWE offers the advantage of being non-invasive, rapid, and repeatable, making it a preferred modality for assessing liver stiffness in clinical practice.

Training cohort; Validation cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cirrhosis and portal hypertension

You may qualify if:

• Age: 18-75 years old;
• Clinical diagnosis of liver cirrhosis (confirmed by pathological biopsy, imaging findings, or occurrence of relevant complications);
• Scheduled for hepatic venous pressure gradient (HVPG) examination;
• Planned to undergo measurement of liver and spleen stiffness using E imaging technology;
• Voluntary signing of informed consent form.

You may not qualify if:

• Contraindications to hepatic venous pressure gradient examination;
• Liver intervention surgery scheduled between E imaging examination and HVPG examination;
• Interval between E imaging examination and HVPG examination exceeds 14 days;
• Presence of liver cancer;
• Concurrent active, severe, life-threatening diseases;
• History of the following surgeries: ① Transjugular intrahepatic portosystemic shunt (TIPS) procedure; ② Hepatectomy; ③ Splenectomy; ④ Liver transplantation.

Sponsors & Collaborators

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

Related Publications (3)

• de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.

  PMID: 35120736 RESULT

• Kaplan DE, Ripoll C, Thiele M, Fortune BE, Simonetto DA, Garcia-Tsao G, Bosch J. AASLD Practice Guidance on risk stratification and management of portal hypertension and varices in cirrhosis. Hepatology. 2024 May 1;79(5):1180-1211. doi: 10.1097/HEP.0000000000000647. Epub 2023 Oct 23. No abstract available.

  PMID: 37870298 RESULT

• Dajti E, Ravaioli F, Zykus R, Rautou PE, Elkrief L, Grgurevic I, Stefanescu H, Hirooka M, Fraquelli M, Rosselli M, Chang PEJ, Piscaglia F, Reiberger T, Llop E, Mueller S, Marasco G, Berzigotti A, Colli A, Festi D, Colecchia A; Spleen Stiffness-IPD-MA Study Group. Accuracy of spleen stiffness measurement for the diagnosis of clinically significant portal hypertension in patients with compensated advanced chronic liver disease: a systematic review and individual patient data meta-analysis. Lancet Gastroenterol Hepatol. 2023 Sep;8(9):816-828. doi: 10.1016/S2468-1253(23)00150-4. Epub 2023 Jul 18.

  PMID: 37478880 RESULT

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

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

Study Officials

• Bin Wu, Professor

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifei Huang, Doctor

CONTACT

huangyf1995@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 10, 2024
• Study Start: April 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share