Trials / Completed
CompletedNCT03766880
MR-based Models for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)
MR-based Models for Noninvasive Detection of Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 175 (actual)
- Sponsor
- Nanfang Hospital, Southern Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-12-04
- Primary completion
- 2019-04-30
- Completion
- 2019-04-30
- First posted
- 2018-12-06
- Last updated
- 2019-08-28
Locations
11 sites across 2 countries: China, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT03766880. Inclusion in this directory is not an endorsement.