Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06358092
Other study ID # ZSSYXHNK2401
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date January 1, 2026

Study information

Verified date April 2024
Source Third Affiliated Hospital, Sun Yat-Sen University
Contact Yifei Huang, Doctor
Email huangyf1995@foxmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

Portal hypertension is an important risk factor affecting the clinical prognosis of patients with liver cirrhosis. According to clinical practice guidelines, risk stratification based on portal vein pressure levels is crucial for predicting the prognosis of patients with cirrhotic portal hypertension, and it is one of the most important aspects in the diagnosis and treatment chain of end-stage liver diseases such as cirrhosis. The most reliable method for assessing portal vein pressure in patients with cirrhosis is the measurement of hepatic venous pressure gradient (HVPG). This is achieved by inserting a catheter into the hepatic vein via jugular vein puncture, measuring the free and wedged pressures, and calculating the difference to obtain HVPG. HVPG provides important information regarding treatment response, complication risks, and long-term prognosis for patients with cirrhotic portal hypertension: HVPG ≥ 10mmHg indicates an increased risk of varices, decompensation events, and hepatocellular carcinoma in compensated cirrhosis patients, HVPG ≥ 12mmHg is a high-risk factor for variceal bleeding, HVPG ≥ 16mmHg suggests an increased risk of death in patients with cirrhotic portal hypertension, and HVPG ≥ 20mmHg indicates higher failure rates of hemostatic treatment and increased mortality risk in patients with acute variceal bleeding. However, there are some issues with measuring HVPG, including invasiveness, technical requirements, and high costs, which limit its clinical application. The development of non-invasive assessment techniques for portal hypertension in cirrhosis has always been a hotspot and difficulty in this field. In recent years, with the rapid development of ultrasound elastography technology, it has also been widely used in the field of liver diseases. Transient elastography, point shear wave elastography, and two-dimensional shear wave elastography (referred to as E imaging) all have important value in the non-invasive assessment of portal hypertension in cirrhosis. Ultrasound elastography, due to its advantages of non-invasiveness, rapidity, ease of operation, repeatability, safety, and ease of follow-up monitoring, is of great significance in risk stratification, precise management, and efficacy evaluation of portal hypertension in cirrhosis. Although liver stiffness has been applied in the diagnosis, treatment, and prognosis assessment of cirrhotic portal hypertension, transient elastography is still the main ultrasound elastography technique used clinically, and there are relatively few original studies related to spleen stiffness. Therefore, there is currently a lack of high-level clinical evidence based on E imaging technology for evaluating portal hypertension in cirrhosis in China, as well as a lack of original research on spleen stiffness assessment in cirrhotic portal hypertension. In 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 112
Est. completion date January 1, 2026
Est. primary completion date January 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Age: 18-75 years old; 2. Clinical diagnosis of liver cirrhosis (confirmed by pathological biopsy, imaging findings, or occurrence of relevant complications); 3. Scheduled for hepatic venous pressure gradient (HVPG) examination; 4. Planned to undergo measurement of liver and spleen stiffness using E imaging technology; 5. Voluntary signing of informed consent form. Exclusion Criteria: 1. Contraindications to hepatic venous pressure gradient examination; 2. Liver intervention surgery scheduled between E imaging examination and HVPG examination; 3. Interval between E imaging examination and HVPG examination exceeds 14 days; 4. Presence of liver cancer; 5. Concurrent active, severe, life-threatening diseases; 6. History of the following surgeries: ? Transjugular intrahepatic portosystemic shunt (TIPS) procedure; ? Hepatectomy; ? Splenectomy; ? Liver transplantation.

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

References & Publications (3)

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 Stud — View Citation

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. Erratum In: J Hepatol. 2022 Apr — View Citation

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. 2023 Oct 23. doi: 10.1097/HEP.0000000000000647. Onl — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 the diagnostic performance of microvessel imaging of hepatic microcirculation by E imaging technology for clinically significant portal hypertension Using HVPG as the gold standard, the diagnostic performance of microvessel imaging of hepatic microcirculation based on E imaging technology for clinically significant portal hypertension. 1 year
Secondary the difference among left, middle and right hepatic venous pressure gradient the difference among left, middle and right hepatic venous pressure gradient 1 year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05052892 - A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105)
Recruiting NCT05251272 - A Combined Model Based on Spleen Stiffness, Liver Stiffness and Platelets for Assessing Portal Hypertension in Compensated Cirrhosis (CHESS2202)
Recruiting NCT05928624 - A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients N/A
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Not yet recruiting NCT05515861 - Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices N/A
Recruiting NCT02364297 - TIPS in Fundal Variceal Bleeding (the TFB Study) N/A
Recruiting NCT01358123 - Value of Von Willebrand Factor in Portal Hypertension N/A
Completed NCT00493480 - Danish Carvedilol Study in Portal Hypertension Phase 3
Recruiting NCT06266260 - Evaluation of the Performance of Direct Portal Pressure Measurement by Endoscopic Ultrasound in a Large Cohort of Patients With Advanced Chronic Liver Disease of Different Etiologies and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP)
Recruiting NCT03277651 - Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension N/A
Active, not recruiting NCT03736265 - Carvedilol for Prevention of Esophageal Varices Progression N/A
Completed NCT03451149 - Feasibility And Safety Of Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation Using A Radiofrequency Guidewire N/A
Completed NCT02994485 - Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin Phase 4
Completed NCT01923064 - Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices N/A
Completed NCT01851252 - MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy Phase 1
Completed NCT01456286 - Randomized Controlled Trial to Assess the Effects of Sapropterin on Hepatic and Systemic Hemodynamics in Patients With Liver Cirrhosis and Portal Hypertension Phase 2/Phase 3
Completed NCT01551966 - Esophageal Capsule Endoscopy in Children N/A
Completed NCT02344719 - Effect of Taurine on Portal Hemodynamics in Patients With Advanced Liver Cirrhosis Phase 4
Recruiting NCT00414713 - Transfusion Requirements in Gastrointestinal (GI) Bleeding Phase 4
Completed NCT00766805 - Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis N/A