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

NCT ID: NCT05251272

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2024-09-27

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 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

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.

Conditions

Portal Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Training cohort

Patients were fulfilled diagnosis of compensated cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations.

Hepatic venous pressure gradient

Intervention Type: DIAGNOSTIC_TEST

All patients underwent measurement of HVPG under local anesthesia.

Validation cohort

Patients were fulfilled diagnosis of compensated cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations.

Hepatic venous pressure gradient

Intervention Type: DIAGNOSTIC_TEST

All patients underwent measurement of HVPG under local anesthesia.

Interventions

Hepatic venous pressure gradient

All patients underwent measurement of HVPG under local anesthesia.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. age above or equal to 18-year-old

2. fulfilled diagnosis of compensated cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations

3. without decompensated events (e.g. ascites, bleeding, or overt encephalopathy)

4. with spleen stiffness and liver stiffness by a dedicated probe on transient elastography examination and platelet count measurement

5. with HVPG measurement

6. signed informed consent

Exclusion Criteria

1. non-cirrhotic portal hypertension

2. accepted primary prevention (non-selective beta blockers or endoscopic variceal ligation)

3. lactation or pregnancy

4. suspicious or confirmed hepatocellular carcinoma

5. asplenia or splenectomy

6. incomplete clinical information

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LanZhou University

OTHER

Sponsor Role: collaborator

Shulan (Hangzhou) Hospital

OTHER

Sponsor Role: collaborator

The Third People's Hospital of Taiyuan

OTHER

Sponsor Role: collaborator

QuFu People's Hospital

INDIV

Sponsor Role: collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: collaborator

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role: lead

Responsible Party

Xiaolong Qi

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lanjuan Li, M.D.

Role: STUDY_CHAIR

Shulan (Hangzhou) Hospital

Xiaolong QI, M.D.

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Huadong Yan, M.D.

Role: STUDY_DIRECTOR

Shulan (Hangzhou) Hospital

Locations

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Site Status: RECRUITING

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status: NOT_YET_RECRUITING

Qufu People's Hospital

Jining, Shandong, China

Site Status: NOT_YET_RECRUITING

The Third People's Hospital of Taiyuan

Taiyuan, Shanxi, China

Site Status: NOT_YET_RECRUITING

Shulan (Hangzhou) Hospital

Hangzhou, Zhejiang, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Xiaolong QI, M.D.

Role: CONTACT

qixiaolong@vip.163.com

+8618588602600

Ruiling He, M.D.

Role: CONTACT

1037039754@qq.com

18153674392

Facility Contacts

Liting Zhang, M.D.

Role: primary

Yuzheng Zhuge, M.D.

Role: primary

Shirong Liu, M.D.

Role: primary

Ying Guo, M.D.

Role: primary

Huadong Yan, M.D.

Role: primary

References

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Reference Type: BACKGROUND

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Other Identifiers

CHESS2202

Identifier Type: -

Identifier Source: org_study_id