A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105)

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 FibroScan had shown good performance for predicting clinically significant portal hypertension. However, the correlation between liver stiffness and HVPG was poor when HVPG was more than 12mmHg. 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 FibroScan was proposed. The prospective, multicenter study aims to evaluate the correlation between SS (measured by the novel FibroScan) and HVPG, and further develop a novel model based on SS for predicting the liver decompensation in patients with compenstaed 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 FibroScan had shown good performance for predicting clinically significant portal hypertension. However, the correlation between liver stiffness and HVPG was poor when HVPG was more than 12mmHg. 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 FibroScan was proposed. The prospective, multicenter study (CHESS2105 leaded by The First Hospital of Lanzhou University and Shulan (Hangzhou) Hospital) aims to evaluate the correlation between SS (measured by the novel FibroScan) and HVPG, and further develop a novel model based on SS for predicting the liver decompensation in patients with compenstaed cirrhosis.

Official Title
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A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105): A Prospective, Multicenter Study

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 cirrhosis based on radiological, histological features of liver cirrhosis signed informed consent Exclusion criteria: Non-cirrhotic portal hypertension 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 cirrhosis based on radiological, histological features of liver cirrhosis. | 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 cirrhosis based on radiological, histological features of liver cirrhosis. | 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) measured by transient elastography for diagnosing portal hypertension. | In HVPG (mmHg) as reference method in evaluating portal pressure measured by intervention specialist , to develop a new model based on spleen stiffness (kPa) measured by transient elastography and evaluate the accuracy in diagnosing portal hypertension. | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of model based on spleen stiffness (kPa) measured by transient elastography for predicting incidence of liver decompensation in patients with compenstaed cirrhosis | To develop a novel model based on spleen stiffness (kPa) measured by transient elastography for predicting the incidence of liver decompensation in patients with compenstaed cirrhosis. | 3 years | 

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