MR-based Models for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)

August 26, 2019 updated by: Xiaolong Qi, Nanfang Hospital of Southern Medical University

MR-based Models for Noninvasive Detection of Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)

Clinically significant portal hypertension (CSPH) is associated with an incremental risk of esophageal varices and overt clinical decompensations in cirrhosis. However, hepatic venous pressure gradient (HVPG) measurement, the gold standard for defining CSPH (HVPG≥ 10mmHg) is invasive and therefore not suitable for routine clinical practice.

This is a multi-center diagnostic trial conducted at high-volume liver centres designed to determine the accuracy of MR-based models (investigational technology) for noninvasive detection of a CSPH in patients with cirrhosis. Transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of CSPH.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinically significant portal hypertension (CSPH) is associated with an incremental risk of esophageal varices and overt clinical decompensations in cirrhosis. However, hepatic venous pressure gradient (HVPG) measurement, the gold standard for defining CSPH (HVPG≥ 10mmHg) is invasive and therefore not suitable for routine clinical practice.

This is a multi-center diagnostic trial conducted at high-volume liver centres (Zhongda Hospital, Medical School of Southeast University; Affiliated Lishui Hospital of Zhejiang University; Shandong Provincial Hospital affiliated to Shandong University; Beijing 302 Hospital; Xingtai People's Hospital; Shunde Hospital, Southern Medical University; The First Hospital of Zhengzhou University; Shanghai Public Health Clinical Center, Fudan University; The First Hospital of Lanzhou University; Nanfang Hospital of Southern Medical University; Ankara University School of Medicine) designed to determine the accuracy of MR-based models (investigational technology) for noninvasive detection of a CSPH in patients with cirrhosis. Transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of CSPH.

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing 302 Hospital
    • Gansu
      • Lanzhou, Gansu, China
        • The First Hospital of Lanzhou University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Nanfang Hospital of Southern Medical University
      • Shunde, Guangdong, China
        • Shunde Hospital, Southern Medical University
    • Hebei
      • Xingtai, Hebei, China
        • Xingtai People's Hospital
    • Henan
      • Zhengzhou, Henan, China
        • The First Hospital of Zhengzhou University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Zhongda Hospital, Medical School of Southeast University
    • Shandong
      • Jinan, Shandong, China
        • Shandong Provincial Hospital Affiliated to Shandong University
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Public Health Clinical Center, Fudan University
    • Zhejiang
      • Lishui, Zhejiang, China
        • Affiliated Lishui Hospital of Zhejiang University
  • Turkey
      • Ankara, Turkey
        • Ankara University School of Medicine

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-75 years
  • With written informed consent
  • Confirmed liver cirrhosis based on liver biopsy or clinical findings
  • Scheduled to undergo clinically-indicated transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter
  • Has undergone> MR imaging within 14 days to hepatic vein catheterization
  • No hepatic-portal vein interventional therapy between MR imaging and hepatic vein catheterization

Exclusion Criteria:

  • A contraindication to MR imaging, in particular pacemakers or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or brain metallic foreign bodies, endo prothesis since less than 4 weeks or osteosynthesis material since less than 6 weeks
  • Unable to comply with breathing or other imaging related instructions resulting in inability to obtain diagnostic quality MR imaging studies
  • Contraindication to the injection of contrast agent: pregnancy, lactation, history of allergic reaction to contrast agent injection.
  • Prior transjugular intrahepatic portosystem stent-shunt surgery
  • Prior devascularization operation
  • Has received a liver transplant
  • Any active, serious, life-threatening disease

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm study
Participants will receive MR imaging, transjugular HVPG measurement, and analysis per protocol.
Procedure: Transjugular HVPG measurement
By means of catheterization of a hepatic vein with a balloon catheter.
Procedure: MR imaging
MR images for the post-processing analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Performance of MR-based Models
Time Frame: 1 day
Accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MR-based models for noninvasive detection of CSPH when compared to HVPG as the reference standard.
1 day

Collaborators and Investigators

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

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

LanZhou University
Beijing 302 Hospital
Shandong Provincial Hospital
Zhongda Hospital
Ankara University
Xingtai People's Hospital
Southern Medical University, China
The First Hospital of Zhengzhou University
Affiliated Lishui Hospital of Zhejiang University
Shanghai Public Health Clinical Center, Fudan University

Investigators

  • Principal Investigator: Shenghong Ju, MD, Zhongda 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)

December 4, 2018

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHESS1802

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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