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

Primary Purpose

Hypertension, Portal

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Transjugular HVPG measurement
MR imaging
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension, Portal focused on measuring clinically significant portal hypertension, hepatic venous pressure gradient, MR imaging

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm study

Arm Description

Participants will receive MR imaging, transjugular HVPG measurement, and analysis per protocol.

Outcomes

Primary Outcome Measures

Diagnostic Performance of MR-based Models
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.

Secondary Outcome Measures

Full Information

First Posted
December 4, 2018
Last Updated
August 26, 2019
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Zhongda Hospital, 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, Southern Medical University, China, Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT03766880
Brief Title
MR-based Models for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)
Official Title
MR-based Models for Noninvasive Detection of Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Zhongda Hospital, 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, Southern Medical University, China, Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Portal
Keywords
clinically significant portal hypertension, hepatic venous pressure gradient, MR imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm study
Arm Type
Experimental
Arm Description
Participants will receive MR imaging, transjugular HVPG measurement, and analysis per protocol.
Intervention Type
Procedure
Intervention Name(s)
Transjugular HVPG measurement
Intervention Description
By means of catheterization of a hepatic vein with a balloon catheter.
Intervention Type
Procedure
Intervention Name(s)
MR imaging
Intervention Description
MR images for the post-processing analysis
Primary Outcome Measure Information:
Title
Diagnostic Performance of MR-based Models
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolong Qi, MD
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shenghong Ju, MD
Organizational Affiliation
Zhongda Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing 302 Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
Country
China
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Shunde Hospital, Southern Medical University
City
Shunde
State/Province
Guangdong
Country
China
Facility Name
Xingtai People's Hospital
City
Xingtai
State/Province
Hebei
Country
China
Facility Name
The First Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Zhongda Hospital, Medical School of Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Shandong Provincial Hospital affiliated to Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Shanghai Public Health Clinical Center, Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Affiliated Lishui Hospital of Zhejiang University
City
Lishui
State/Province
Zhejiang
Country
China
Facility Name
Ankara University School of Medicine
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Citation
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MR-based Models for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)

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