A Combined Model Based on Spleen Stiffness, Liver Stiffness and Platelets for Assessing Portal Hypertension in Compensated Cirrhosis (CHESS2202)
NCT05251272 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2023-04-25
Summary
Portal hypertension contributed to the main complications of liver cirrhosis. Currently, hepatic venous pressure gradient (HVPG) was the reference standard for evaluating portal pressure in patients with cirrhosis. However, the practice of HVPG is limited to require the extensive experience and highly specialized centers. In recent years, non-invasive methods were proposed to predict the degree of cirrhotic portal hypertension. Of them, liver stiffness measured by transient elastography had shown good performance for predicting clinically significant portal hypertension. However, liver stiffness only has a good correlation with portal pressure in the early stage of portal hypertension (HVPG\<10 mmHg), because liver fibrosis is the main cause of portal hypertension in this period. In the stage of clinically significant portal hypertension (CSPH) (HVPG≥10 mmHg), increased portal vein inflow due to splanchnic vasodilation and hyperdynamic circulation, spleen stiffness may have a better correlation with HVPG than that of liver stiffness. Several studies have explored the combination of liver stiffness, platelet count and spleen stiffness for varices screening. However, there are few studies to report the above parameters for assessing CSPH and unneeded HVPG avoiding.
Since the spleen was stiffer than the liver, the current vibration-controlled transient elastography examination is dedicated to the liver, rather than the spleen. Very recently, a novel spleen-dedicated stiffness measured by transient elastography was proposed. The prospective, multicenter study aims to add spleen stiffness as a supplementary parameter to establish new criteria for identify CSPH in patients with compensated cirrhosis, with a dedicated probe on transient elastography equipment to assess spleen stiffness and liver stiffness, and further develop a novel model based on spleen stiffness for predicting the liver decompensation in patients with compensated cirrhosis.
Conditions
- Portal Hypertension
Interventions
- DIAGNOSTIC_TEST
-
Hepatic venous pressure gradient
All patients underwent measurement of HVPG under local anesthesia.
Sponsors & Collaborators
-
LanZhou University
collaborator OTHER -
Shulan (Hangzhou) Hospital
collaborator OTHER -
The Third People's Hospital of Taiyuan
collaborator OTHER -
QuFu People's Hospital
collaborator INDIV -
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
collaborator OTHER -
Hepatopancreatobiliary Surgery Institute of Gansu Province
lead OTHER
Principal Investigators
-
Lanjuan Li, M.D. · Shulan (Hangzhou) Hospital
-
Xiaolong QI, M.D. · LanZhou University
-
Huadong Yan, M.D. · Shulan (Hangzhou) Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-28
- Primary Completion
- 2024-09-27
- Completion
- 2024-09-27
Countries
- China
Study Locations
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