A Combined Model Based on Spleen Stiffness, Liver Stiffness and Platelets for Assessing Portal Hypertension in Compensated Cirrhosis (CHESS2202)

Study Overview
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Brief Summary
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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.

Detailed Description
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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 (leaded by The First Hospital of Lanzhou University and Shulan (Hangzhou) Hospital) 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.

Official Title
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A Combined Model Based on Spleen Stiffness, Liver Stiffness and Platelets for Assessing Portal Hypertension in Compensated Cirrhosis: A Prospective, Multicenter Study (CHESS2202)

Conditions
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Portal Hypertension

Intervention / Treatment
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* Diagnostic Test: Hepatic venous pressure gradient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age above or equal to 18-year-old fulfilled diagnosis of compensated cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations without decompensated events (e.g. ascites, bleeding, or overt encephalopathy) with spleen stiffness and liver stiffness by a dedicated probe on transient elastography examination and platelet count measurement with HVPG measurement signed informed consent Exclusion Criteria: non-cirrhotic portal hypertension accepted primary prevention (non-selective beta blockers or endoscopic variceal ligation) lactation or pregnancy suspicious or confirmed hepatocellular carcinoma asplenia or splenectomy incomplete clinical information

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training cohort<br>Patients were fulfilled diagnosis of compensated cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations. | Diagnostic Test: Hepatic venous pressure gradient<br>* All patients underwent measurement of HVPG under local anesthesia.<br>|
| Validation cohort<br>Patients were fulfilled diagnosis of compensated cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations. | Diagnostic Test: Hepatic venous pressure gradient<br>* All patients underwent measurement of HVPG under local anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of a new model based on spleen stiffness (kPa), liver stiffness (kPa) or platelets (/L) for assessing portal hypertension in compensated cirrhosis. | In HVPG (mmHg) as reference method in evaluating portal pressure measured by intervention specialist, to develop a new model based on spleen stiffness (kPa), liver stiffness (kPa) or platelets (/L) and evaluate the accuracy in diagnosing portal hypertension. Spleen stiffness (kPa) and liver stiffness (kPa) are measured by transient elastography with a dedicated probe. | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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compensated cirrhosis, spleen stiffness, liver stiffness, portal hypertension, hepatic venous pressure gradient