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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05052892

Enrollment

1000

Registered

2021-09-22

Start date

2023-09-28

Completion date

2025-09-27

Last updated

2023-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal Hypertension

Keywords

cirrhosis, spleen stiffness, portal hypertension, hepatic venous pressure gradient

Brief 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 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

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.

Interventions

DIAGNOSTIC_TESTHepatic venous pressure gradient

All patients underwent measurement of HVPG under local anesthesia.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of a new model based on spleen stiffness (kPa) measured by transient elastography for diagnosing portal hypertension.	1 years	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.

Secondary

Measure	Time frame	Description
Accuracy of model based on spleen stiffness (kPa) measured by transient elastography for predicting incidence of liver decompensation in patients with compenstaed cirrhosis	3 years	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.

Countries

China

Contacts

Primary ContactXiaolong Qi, MD

qixiaolong@vip.163.com+8618588602600

Backup ContactRuiling He, MD

1037039754@qq.com+8618153674392

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026