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

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03766880
Collaborator
Zhongda Hospital, Medical School of Southeast University (Other), Beijing 302 Hospital (Other), Affiliated Lishui Hospital of Zhejiang University (Other), Shandong Provincial Hospital (Other), Xingtai People's Hospital (Other), The First Hospital of Zhengzhou University (Other), Shanghai Public Health Clinical Center, Fudan University (Other), LanZhou University (Other), Shunde Hospital, Southern Medical University (Other), Ankara University (Other)
175
Enrollment
11
Locations
1
Arm
4.8
Actual Duration (Months)
15.9
Patients Per Site
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transjugular HVPG measurement
  • Procedure: MR imaging
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
175 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
MR-based Models for Noninvasive Detection of Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)
Actual Study Start Date :
Dec 4, 2018
Actual Primary Completion Date :
Apr 30, 2019
Actual Study Completion Date :
Apr 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Diagnostic Performance of MR-based Models [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing 302 Hospital Beijing Beijing China
2 The First Hospital of Lanzhou University Lanzhou Gansu China
3 Nanfang Hospital of Southern Medical University Guangzhou Guangdong China
4 Shunde Hospital, Southern Medical University Shunde Guangdong China
5 Xingtai People's Hospital Xingtai Hebei China
6 The First Hospital of Zhengzhou University Zhengzhou Henan China
7 Zhongda Hospital, Medical School of Southeast University Nanjing Jiangsu China
8 Shandong Provincial Hospital affiliated to Shandong University Jinan Shandong China
9 Shanghai Public Health Clinical Center, Fudan University Shanghai Shanghai China
10 Affiliated Lishui Hospital of Zhejiang University Lishui Zhejiang China
11 Ankara University School of Medicine Ankara Turkey

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Xiaolong Qi, MD, Nanfang Hospital of Southern Medical University
  • Principal Investigator: Shenghong Ju, MD, Zhongda Hospital, Medical School of Southeast University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xiaolong Qi, Director, Hepatic Hemodynamic Lab, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT03766880
Other Study ID Numbers:
  • CHESS1802
First Posted:
Dec 6, 2018
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xiaolong Qi, Director, Hepatic Hemodynamic Lab, Nanfang Hospital of Southern Medical University
clinically significant portal hypertension, hepatic venous pressure gradient, MR imaging
Additional relevant MeSH terms:
Hypertension, Portal
Hypertension

Study Results

No Results Posted as of Aug 28, 2019