Portal HypertensionNCT06316869
Noninvasive Prediction of Portal Hypertension in Cirrhosis Using Sound Touch Viscoelastography
An observational study of Portal Hypertension and Cirrhosis, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Hypertension, Cirrhosis
- What is being tested?
- ultrasound test
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2024to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Portal Hypertension (PH) is the primary consequence of liver cirrhosis and a crucial factor leading to severe complications such as ascites, rupture and bleeding of esophageal and gastric varices (EGV), and hepatic encephalopathy. It annually results in a significant number of deaths, posing a serious threat to life and health. In China, there is a large population of PH patients, and the long-term follow-up and treatment processes require substantial medical resources. Currently, there is no reliable non-invasive method for convenient and rapid monitoring of portal vein pressure in PH patients. This hinders timely clinical intervention and compromises patient prognosis.
Who may be able to join
- Age older than 18 years.
- Clinically diagnosed with cirrhosis. Meeting the diagnostic criteria of the 2019 edition of the "Cirrhosis Diagnosis and Treatment Guidelines": (1) Histology consistent with cirrhosis diagnosis; (2) Endoscopy shows esophageal gastric varices or ectopic varices, excluding non-cirrhotic portal hypertension; (3) Imaging examinations such as ultrasound, LSM, or CT suggest features of cirrhosis or portal hypertension: such as splenomegaly, portal vein ≥1.3 cm, LSM measurements meeting diagnostic thresholds for cirrhosis of different etiologies; (4) In the absence of histology, endoscopy, or imaging examinations, the following abnormal indicators suggest the presence of cirrhosis (must meet 2 of the 4 criteria): a. PLT <100×10^9/L, with no other explanations; b. Serum ALB <35 g/L, excluding malnutrition or other causes such as renal disease; c. INR >1.3 or prolonged PT (discontinuation of thrombolytics or anticoagulants for >7 days); d. AST/PLT ratio index (APRI): Adult APRI score >2, with attention to the influence of hepatotoxic drugs and other factors on APRI.
- Planning to undergo HVPG testing and meeting the indications for HVPG testing in the "Chinese Expert Consensus on the Clinical Application of Hepatic Venous Pressure Gradient (2018 edition)" : (1) Assessing the efficacy of drug therapy for primary and secondary prevention of esophageal gastric variceal bleeding; (2) Predicting the risk of esophageal gastric variceal bleeding and guiding treatment plan selection; (3) Predicting the risk, degree of progression, and clinical prognosis of decompensated events in cirrhosis; (4) Evaluating the efficacy of related new drugs; (5) Evaluating the accuracy of related non-invasive techniques; (6) Diagnosis and differential diagnosis of portal hypertension types.
- Able to understand and voluntarily sign a written informed consent form.
Who cannot join
- Post-TIPS procedure;
- Post-hepatectomy splenectomy;
- Hepatic malignancy;
- Portal vein thrombosis;
- Individuals with severe cardiac, pulmonary, hepatic, or renal dysfunction;
- Pregnant and postpartum women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325006
Shihao Xu, doctor's degree, 13857766918, dcxshvip@wmu.edu.cn
Shihao Xu
About this study
Official title: Clinical Study of Noninvasive Prediction of Portal Hypertension in Cirrhosis Based on Sound Touch Viscoelastography
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 this 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.
Read the detailed description
- 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..
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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).
- Conditions
- Portal Hypertension, Cirrhosis
- Being tested
- ultrasound test
- Keywords
- Sound Touch Viscoelastography, Clinically Significant Portal Hypertension, Portal Venous Pressure Gradient, Cirrhosis
- Medical subject headings
- Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound testDiagnostic test
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.
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
| Study group | Role | What they receive |
|---|---|---|
| CSPH group | HVPG≥10 mmHg Receives: Diagnostic Test: ultrasound test | |
| Non-CSPH group | HVPG<10 mmHg Receives: Diagnostic Test: ultrasound test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The STVi index
The ultrasound STVi index is derived from the acoustic factors that describe the variation of shear wave speed with frequency. The abdominal convex array probe equipped with the color Doppler ultrasound system (including elastic components) was used to measure the shear wave signals.This index is calculated using the Voigt model and a linear relationship model to determine viscosity and dispersion, employing specific computer algorithms to obtain the final value. Since the STVi index is a new evaluation metric based on novel ultrasound technology, no clear maximum or minimum values have been reported. STVi index is significantly higher in the CSPH group than in the non-CSPH group.
Measured: baseline, pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start2 Sep 2024
- Primary completion20 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316869
- Sponsor's protocol ID
- STVi
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Noninvasive Prediction of Portal Hypertension in Cirrhosis Based on Sound Touch Viscoelastography
- ClinicalTrials.gov ID
- NCT06316869
- Acronym / sponsor ID
- STVi
- Conditions
- Portal Hypertension, Cirrhosis
- Keywords
- Sound Touch Viscoelastography, Clinically Significant Portal Hypertension, Portal Venous Pressure Gradient, Cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 this 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.
Detailed description
- 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..
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSPH group | – | Diagnostic Test: ultrasound testHVPG≥10 mmHg |
| Non-CSPH group | – | Diagnostic Test: ultrasound testHVPG<10 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Portal Hypertension (PH) is the primary consequence of liver cirrhosis and a crucial factor leading to severe complications such as ascites, rupture and bleeding of esophageal and gastric varices (EGV), and hepatic encephalopathy. It annually results in a significant number of deaths, posing a serious threat to life and health. In China, there is a large population of PH patients, and the long-term follow-up and treatment processes require substantial medical resources. Currently, there is no reliable non-invasive method for convenient and rapid monitoring of portal vein pressure in PH patients. This hinders timely clinical intervention and compromises patient prognosis.
Key inclusion criteria (4 listed)
- Age older than 18 years.
- Clinically diagnosed with cirrhosis. Meeting the diagnostic criteria of the 2019 edition of the "Cirrhosis Diagnosis and Treatment Guidelines": (1) Histology consistent with cirrhosis diagnosis; (2) Endoscopy shows esophageal gastric varices or ectopic varices, excluding non-cirrhotic portal hypertension; (3) Imaging examinations such as ultrasound, LSM, or CT suggest features of cirrhosis or portal hypertension: such as splenomegaly, portal vein ≥1.3 cm, LSM measurements meeting diagnostic thresholds for cirrhosis of different etiologies; (4) In the absence of histology, endoscopy, or imaging examinations, the following abnormal indicators suggest the presence of cirrhosis (must meet 2 of the 4 criteria): a. PLT <100×10^9/L, with no other explanations; b. Serum ALB <35 g/L, excluding malnutrition or other causes such as renal disease; c. INR >1.3 or prolonged PT (discontinuation of thrombolytics or anticoagulants for >7 days); d. AST/PLT ratio index (APRI): Adult APRI score >2, with attention to the influence of hepatotoxic drugs and other factors on APRI.
- Planning to undergo HVPG testing and meeting the indications for HVPG testing in the "Chinese Expert Consensus on the Clinical Application of Hepatic Venous Pressure Gradient (2018 edition)" : (1) Assessing the efficacy of drug therapy for primary and secondary prevention of esophageal gastric variceal bleeding; (2) Predicting the risk of esophageal gastric variceal bleeding and guiding treatment plan selection; (3) Predicting the risk, degree of progression, and clinical prognosis of decompensated events in cirrhosis; (4) Evaluating the efficacy of related new drugs; (5) Evaluating the accuracy of related non-invasive techniques; (6) Diagnosis and differential diagnosis of portal hypertension types.
- Able to understand and voluntarily sign a written informed consent form.
Key exclusion criteria (6 listed)
- Post-TIPS procedure;
- Post-hepatectomy splenectomy;
- Hepatic malignancy;
- Portal vein thrombosis;
- Individuals with severe cardiac, pulmonary, hepatic, or renal dysfunction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound testConventional 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. 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 | Diagnostic test | CSPH group, Non-CSPH group |
Primary outcome
The STVi index
Time frame: baseline, pre-intervention
The ultrasound STVi index is derived from the acoustic factors that describe the variation of shear wave speed with frequency. The abdominal convex array probe equipped with the color Doppler ultrasound system (including elastic components) was used to measure the shear wave signals.This index is calculated using the Voigt model and a linear relationship model to determine viscosity and dispersion, employing specific computer algorithms to obtain the final value. Since the STVi index is a new evaluation metric based on novel ultrasound technology, no clear maximum or minimum values have been reported. STVi index is significantly higher in the CSPH group than in the non-CSPH group.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension and Cirrhosis, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shihao Xu, doctor (+86 13857766918, dcxshvip@wmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The STVi index (time frame: baseline, pre-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.