Hypertension, Portal Clinical Trial
Official title:
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.
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.
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