Clinical trial NCT05052892: A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105)
Official title: A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105): A Prospective, Multicenter Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Portal Hypertension
Keywords: cirrhosis
spleen stiffness
portal hypertension
hepatic venous pressure gradient
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
Collaborators: name: LanZhou University
name: Shulan (Hangzhou) Hospital
name: The Third People's Hospital of Taiyuan
First posted: 2021-09-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients was fulfilled the diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of a new model based on spleen stiffness (kPa) measured by transient elastography for diagnosing portal hypertension.
timeFrame: 1 years
Secondary outcomes:
measure: Accuracy of model based on spleen stiffness (kPa) measured by transient elastography for predicting incidence of liver decompensation in patients with compenstaed cirrhosis
timeFrame: 3 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Shulan (Hangzhou) Hospital
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
city: Taiyuan
country: China
facility: The Third People's Hospital of Taiyuan
Study officials:
affiliation: Shulan (Hangzhou) Hospital
name: Lanjuan Li, MD
role: STUDY_CHAIR
affiliation: LanZhou University
name: Xiaolong Qi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shulan (Hangzhou) Hospital
name: Huadong Yan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bastard C, Miette V, Cales P, Stefanescu H, Festi D, Sandrin L. A Novel FibroScan Examination Dedicated to Spleen Stiffness Measurement. Ultrasound Med Biol. 2018 Aug;44(8):1616-1626. doi: 10.1016/j.ultrasmedbio.2018.03.028. Epub 2018 May 3.
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