Trials / Completed
CompletedNCT02842697
Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601)
Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Nanfang Hospital, Southern Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-center trial conducted at 1 Guangzhou and 2 Beijing centers designed to determine the diagnostic performance of virtual hepatic venous pressure gradient (vHVPG) (investigational technology) by anatomic computed tomographic angiography (CTA) for non-invasive assessment of the clinically significant portal hypertension (CSPH) in patients with compensated cirrhosis. Direct hepatic venous pressure gradient (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, which is defined as HVPG≥10 mmHg.
Detailed description
This is a prospective, multi-center trial conducted at 1 Guangzhou (Nanfang Hospital) and 2 Beijing (Beijing 302 Hospital, Beijing Shijitan Hospital) centers designed to determine the diagnostic performance of vHVPG (investigational technology) by anatomic CTA for non-invasive assessment of the CSPH in patients with compensated cirrhosis. Direct 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, which is defined as HVPG≥10 mmHg.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | HVPG measurement | HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter |
| PROCEDURE | CTA | Three-dimensional hepatic vein-portal vein model constructed with CTA images |
| PROCEDURE | Doppler ultrasound | Portal vein velocity measured by Doppler ultrasound |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2017-04-01
- Completion
- 2017-04-01
- First posted
- 2016-07-25
- Last updated
- 2019-01-08
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02842697. Inclusion in this directory is not an endorsement.