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

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Not yet enrolling

Conditions: Portal Hypertension

Treatments: Diagnostic Test: Hepatic venous pressure gradient

Study type: Observational

Funder types: Other

Identifiers

NCT05052892

CHESS2105

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age above or equal to 18-year-old
2. fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis
3. signed informed consent

Exclusion criteria

1. Non-cirrhotic portal hypertension
2. Lactation or pregnancy
3. Suspicious or confirmed hepatocellular carcinoma
4. Asplenia or splenectomy
5. Incomplete clinical information

Trial design

1,000 participants in 2 patient groups

Training cohort

Description:

Patients were fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis.

Treatment:

Diagnostic Test: Hepatic venous pressure gradient

Validation cohort

Description:

Patients were fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis.

Treatment:

Diagnostic Test: Hepatic venous pressure gradient