Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-10
Brief Title:
Noninvasive Prediction of Portal Hypertension in Cirrhosis Using Sound Touch Viscoelastography
Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Organization:
First Affiliated Hospital of Wenzhou Medical University
Study Overview
Official Title:
Clinical Study of Noninvasive Prediction of Portal Hypertension in Cirrhosis Based on Sound Touch Viscoelastography
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this observational study is to investigate and validate the utility of the Sound Touch ViscoelastographySTVi 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 HVPG10 mmHg and HVPG10 mmHg to see the usage of STVi in the noninvasive prediction of PH
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 HVPG10 mmHg and HVPG10 mmHg to see the usage of STVi in the noninvasive prediction of PH
Detailed 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 16 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 15 cm Take the median after 3 valid measurements of the same site The sampling results require measurement success rate 60 and IQRMedian03
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 24 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 HVPG10 mmHg and non-CSPH group HVPG10 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
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 16 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 15 cm Take the median after 3 valid measurements of the same site The sampling results require measurement success rate 60 and IQRMedian03
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 24 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 HVPG10 mmHg and non-CSPH group HVPG10 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None