Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358092
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-29
Brief Title:
Two-dimensional Shear Wave Elastography for Assessment of Cirrhosis and Portal Hypertension
Sponsor:
Third Affiliated Hospital Sun Yat-Sen University
Organization:
Third Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
Spleen Stiffness and Liver Stiffness Measured by Two-dimensional Shear Wave Elastography for Assessment of Cirrhosis and Portal Hypertension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None