Clinical trial NCT03766880: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Portal
Keywords: clinically significant portal hypertension, hepatic venous pressure gradient, MR imaging
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Zhongda Hospital
name: Beijing 302 Hospital
name: Affiliated Lishui Hospital of Zhejiang University
name: Shandong Provincial Hospital
name: Xingtai People's Hospital
name: The First Hospital of Zhengzhou University
name: Shanghai Public Health Clinical Center, Fudan University
name: LanZhou University
name: Southern Medical University, China
name: Ankara University
First posted: 2018-12-06
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Diagnostic Performance of MR-based Models
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing 302 Hospital
state: Beijing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Shunde
country: China
facility: Shunde Hospital, Southern Medical University
state: Guangdong
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Zhengzhou
country: China
facility: The First Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: Zhongda Hospital, Medical School of Southeast University
state: Jiangsu
city: Jinan
country: China
facility: Shandong Provincial Hospital affiliated to Shandong University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center, Fudan University
state: Shanghai
city: Lishui
country: China
facility: Affiliated Lishui Hospital of Zhejiang University
state: Zhejiang
city: Ankara
country: Turkey
facility: Ankara University School of Medicine
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Xiaolong Qi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongda Hospital
name: Shenghong Ju, MD
role: PRINCIPAL_INVESTIGATOR
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