Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06316869 |
| Other study ID # |
STVi |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2024 |
| Est. completion date |
March 31, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
First Affiliated Hospital of Wenzhou Medical University |
| Contact |
Shihao Xu, doctor |
| Phone |
+86 13857766918 |
| Email |
dcxshvip[@]wmu.edu.cn |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The objective of this observational study is to investigate and validate the utility of the
Sound Touch Viscoelastography(STVi) technique in patients with liver cirrhosis for
noninvasive prediction of Portal hypertension (PH). The primary research questions it seeks
to address are as follows:
- What is the correlation between the liver STVi index and Portal Venous Pressure Gradient
(HVPG)?
- Is STVi an available tool to non-invasively predict PH in patients with liver cirrhosis?
And the effectiveness and practicality of STVi will be validated.
- To establish a predictive model for Clinically Significant Portal Hypertension (CSPH)
utilizing liver STVi index as the primary indicator.
The HVPG is considered as the gold standard in our study and STVi was employed to quantify
the STVi index of the liver in patients with liver cirrhosis. Researchers will compare the
two patients groups, HVPG≥10 mmHg and HVPG<10 mmHg, to see the usage of STVi in the
noninvasive prediction of PH.
Description:
1. Research subjects: Subjects were included in strict accordance with the preparation
procedures (inclusion criteria, informed consent), and with the approval of the Ethics
Committee of the First Affiliated Hospital of Wenzhou Medical University, relevant data
were collected within 1 week after the patients were enrolled and before the HVPG test..
2. Clinical baseline information and laboratory data: including name, gender, age, blood
pressure, BMI (height, weight), causes of liver cirrhosis and other general information,
and relevant laboratory tests, including platelet count, hemoglobin, albumin,
prothrombin time, international normalized ratio, total bilirubin, creatinine, aspartate
aminotransferase, alanine aminotransferase, alkaline phosphatase, blood ammonia, etc.
3. Conventional gray-scale ultrasound and color Doppler examination: including hepatic
artery inner diameter, hepatic artery peak flow velocity, hepatic artery resistance
index, portal vein trunk inner diameter, portal vein average flow velocity, spleen size,
etc.
4. STVi detection: Use the color Doppler ultrasound system (including elastic components)
of Shenzhen Mindray Biomedical Electronics Co., Ltd., equipped with an abdominal convex
array probe with a probe frequency of 1~6 MHz. The probe was placed in a supine position
or slightly tilted to the left, with the right arm raised and fully abducted to increase
the width of the intercostal space, and the liver viscoelastic index of the right lobe
of the liver was measured between the intercostals. During measurement, the subject
should hold his breath for 3 to 5 seconds in a calm state. Do not hold his breath after
taking a deep breath. The sampling frame should be placed in a place with uniform echo
in the liver parenchyma, avoiding large blood vessels, bile ducts and ribs. The sampling
frame should be as parallel to the liver capsule as possible and placed 1 to 2 cm below
the liver capsule and no more than 6 cm. The region of interest is preferably placed in
the center of the elastogram, and the diameter of the sampling frame is recommended to
be ≥1.5 cm. Take the median after 3 valid measurements of the same site. The sampling
results require measurement success rate ≥60% and IQR/Median≤0.3.
5. HVPG detection: Use the right jugular vein approach, refer to the Chinese Expert
Consensus on Clinical Application of Hepatic Venous Pressure Gradient (2018 Edition) ,
and select the balloon catheter to the hepatic vein under fluoroscopy, at a distance
from the inferior vena cava 2~4 cm, wait at least 20 s (some patients may take longer to
reach a stable reading), and then read the Free Hepatic Venous Pressure (FHVP) after the
pressure value is stable. After injecting contrast medium or air to expand the balloon
to fully block the hepatic venous blood flow, wait at least 40 s until the pressure
value is stable, and then read the Hepatic Venous Wedge Pressure (WHVP). Keep the
balloon in the inflated state, instruct the patient to hold his breath, slowly inject 5
ml of contrast agent through the balloon catheter, and perform hepatic venography to
confirm that there is no contrast agent reflux or venous-venous collateral shunt.
Calculated according to the formula HVPG = WHVP - FHVP, HVPG should be the average of 2
measurements.
6. Group according to the HVPG test results and divide them into 2 groups: CSPH group
(HVPG≥10 mmHg) and non-CSPH group (HVPG<10 mmHg).
7. Build a model: Screen out independent variable information related to the occurrence of
CSPH through model variable screening and correlation analysis, and use it to build a
prediction model. And establish a Nomogram model to realize the visualization of the
model.
8. Evaluate the model: Discrimination of the model: ROC curve analysis, C-index;
Calibration of the model: Hosmer-Lemeshow goodness of fit test, consistency curve
(test); Clinical net benefit assessment: Decision curve analysis ( DCA).
