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

April 23, 2023 updated by: Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
          • Liting Zhang, M.D.
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
        • Contact:
          • Yuzheng Zhuge, M.D.
    • Shandong
      • Jining, Shandong, China, 272000
        • Not yet recruiting
        • Qufu People's Hospital
        • Contact:
          • Shirong Liu, M.D.
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Not yet recruiting
        • The Third People's Hospital of Taiyuan
        • Contact:
          • Ying Guo, M.D.
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Shulan (Hangzhou) Hospital
        • Contact:
          • Huadong Yan, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Training cohort
Patients were fulfilled diagnosis of compensated cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations.
Diagnostic test: Hepatic venous pressure gradient
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.
Diagnostic test: Hepatic venous pressure gradient
All patients underwent measurement of HVPG under local anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of a new model based on spleen stiffness (kPa), liver stiffness (kPa) or platelets (/L) for assessing portal hypertension in compensated cirrhosis.
Time Frame: 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), liver stiffness (kPa) or platelets (/L) and evaluate the accuracy in diagnosing portal hypertension.

Spleen stiffness (kPa) and liver stiffness (kPa) are measured by transient elastography with a dedicated probe.
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Collaborators

LanZhou University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The Third People's Hospital of Taiyuan
Shulan (Hangzhou) Hospital
QuFu People's Hospital

Investigators

  • Principal Investigator: Xiaolong QI, M.D., LanZhou University
  • Study Chair: Lanjuan Li, M.D., Shulan (Hangzhou) Hospital
  • Study Director: Huadong Yan, M.D., Shulan (Hangzhou) Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2021

Primary Completion (Anticipated)

September 27, 2024

Study Completion (Anticipated)

September 27, 2024

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHESS2202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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