Cirrhosis, LiverNCT06358092
Two-dimensional Shear Wave Elastography for Assessment of Cirrhosis and Portal Hypertension
An observational study of Cirrhosis, Liver and Portal Hypertension, run by Third Affiliated Hospital, Sun Yat-Sen University.
Trial summary
Exploring and establishing new non-invasive risk stratification techniques for portal hypertension based on E imaging technology for measuring liver and spleen stiffness is an urgent need in this field of research. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Liver, Portal Hypertension
- What is being tested?
- Hepatic venous pressure gradient and Two-Dimensional Shear Wave Elastography
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Jan 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with cirrhosis and portal hypertension
Who may be able to join
- Age: 18-75 years old;
- Clinical diagnosis of liver cirrhosis (confirmed by pathological biopsy, imaging findings, or occurrence of relevant complications);
- Scheduled for hepatic venous pressure gradient (HVPG) examination;
- Planned to undergo measurement of liver and spleen stiffness using E imaging technology;
- Voluntary signing of informed consent form.
Who cannot join
- Contraindications to hepatic venous pressure gradient examination;
- Liver intervention surgery scheduled between E imaging examination and HVPG examination;
- Interval between E imaging examination and HVPG examination exceeds 14 days;
- Presence of liver cancer;
- Concurrent active, severe, life-threatening diseases;
- History of the following surgeries: ① Transjugular intrahepatic portosystemic shunt (TIPS) procedure; ② Hepatectomy; ③ Splenectomy; ④ Liver transplantation.
Trial locations and contacts
No sites are listed yet.
Yifei Huang, Doctor contact
About this study
Official title: Spleen Stiffness and Liver Stiffness Measured by Two-dimensional Shear Wave Elastography for Assessment of Cirrhosis and Portal Hypertension
Exploring and establishing new non-invasive risk stratification techniques for portal hypertension based on E imaging technology for measuring liver and spleen stiffness is an urgent need in this field of research.
Read the detailed description
Portal hypertension is an important risk factor affecting the clinical prognosis of patients with liver cirrhosis. According to clinical practice guidelines, risk stratification based on portal vein pressure levels is crucial for predicting the prognosis of patients with cirrhotic portal hypertension, and it is one of the most important aspects in the diagnosis and treatment chain of end-stage liver diseases such as cirrhosis. The most reliable method for assessing portal vein pressure in patients with cirrhosis is the measurement of hepatic venous pressure gradient (HVPG). This is achieved by inserting a catheter into the hepatic vein via jugular vein puncture, measuring the free and wedged pressures, and calculating the difference to obtain HVPG. HVPG provides important information regarding treatment response, complication risks, and long-term prognosis for patients with cirrhotic portal hypertension: HVPG ≥ 10mmHg indicates an increased risk of varices, decompensation events, and hepatocellular carcinoma in compensated cirrhosis patients, HVPG ≥ 12mmHg is a high-risk factor for variceal bleeding, HVPG ≥ 16mmHg suggests an increased risk of death in patients with cirrhotic portal hypertension, and HVPG ≥ 20mmHg indicates higher failure rates of hemostatic treatment and increased mortality risk in patients with acute variceal bleeding. However, there are some issues with measuring HVPG, including invasiveness, technical requirements, and high costs, which limit its clinical application. The development of non-invasive assessment techniques for portal hypertension in cirrhosis has always been a hotspot and difficulty in this field.
In recent years, with the rapid development of ultrasound elastography technology, it has also been widely used in the field of liver diseases. Transient elastography, point shear wave elastography, and two-dimensional shear wave elastography (referred to as E imaging) all have important value in the non-invasive assessment of portal hypertension in cirrhosis. Ultrasound elastography, due to its advantages of non-invasiveness, rapidity, ease of operation, repeatability, safety, and ease of follow-up monitoring, is of great significance in risk stratification, precise management, and efficacy evaluation of portal hypertension in cirrhosis. Although liver stiffness has been applied in the diagnosis, treatment, and prognosis assessment of cirrhotic portal hypertension, transient elastography is still the main ultrasound elastography technique used clinically, and there are relatively few original studies related to spleen stiffness. Therefore, there is currently a lack of high-level clinical evidence based on E imaging technology for evaluating portal hypertension in cirrhosis in China, as well as a lack of original research on spleen stiffness assessment in cirrhotic portal hypertension.
In summary, exploring and establishing new non-invasive risk stratification techniques for portal hypertension based on E imaging technology for measuring liver and spleen stiffness is an urgent need in this field of research.
- Conditions
- Cirrhosis, Liver, Portal Hypertension
- Being tested
- Hepatic venous pressure gradient, Two-Dimensional Shear Wave Elastography
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic venous pressure gradientDiagnostic test
HVPG is a measurement used to assess portal hypertension, a condition characterized by increased blood pressure in the portal vein, which carries blood from the digestive organs to the liver. HVPG measurement involves inserting a catheter into the hepatic vein via jugular vein puncture to directly measure the pressure within the liver. By comparing the pressure in the hepatic vein with that in the portal vein, HVPG provides valuable information about the severity of portal hypertension and helps in predicting clinical outcomes in patients with liver cirrhosis and related conditions. HVPG measurements are crucial in guiding treatment decisions, assessing treatment response, and predicting the risk of complications such as variceal bleeding and liver failure.
Two-Dimensional Shear Wave ElastographyDiagnostic test
2D-SWE is a non-invasive imaging technique used to assess tissue stiffness, particularly in the liver. This technology utilizes ultrasound to generate shear waves within the tissue being examined. By measuring the speed of these shear waves as they propagate through the tissue, 2D-SWE can provide quantitative information about tissue elasticity or stiffness. In the context of liver disease, including cirrhosis and fibrosis, 2D-SWE is valuable for evaluating the degree of liver stiffness, which correlates with the severity of liver fibrosis. This information aids in diagnosis, staging, and monitoring of liver diseases, allowing for early detection of complications and assessment of treatment response. Compared to traditional biopsy-based methods, 2D-SWE offers the advantage of being non-invasive, rapid, and repeatable, making it a preferred modality for assessing liver stiffness in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | To explore the cut-off value of LSM and SSM by 2D-SWE for assessment of CSPH in cirrhosis. Receives: Diagnostic Test: Hepatic venous pressure gradient; Diagnostic Test: Two-Dimensional Shear Wave Elastography | |
| Validation cohort | To validate the cut-off value of LSM and SSM by 2D-SWE for assessment of CSPH in cirrhosis. Receives: Diagnostic Test: Hepatic venous pressure gradient; Diagnostic Test: Two-Dimensional Shear Wave Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnostic performance of liver and spleen stiffness by E imaging technology for clinically significant portal hypertension
Using HVPG as the gold standard, the diagnostic performance of measuring liver and spleen stiffness based on E imaging technology for clinically significant portal hypertension.
Measured: 1 year
Secondary outcomes (2)
the diagnostic performance of microvessel imaging of hepatic microcirculation by E imaging technology for clinically significant portal hypertension
Using HVPG as the gold standard, the diagnostic performance of microvessel imaging of hepatic microcirculation based on E imaging technology for clinically significant portal hypertension.
Measured: 1 year
the difference among left, middle and right hepatic venous pressure gradient
the difference among left, middle and right hepatic venous pressure gradient
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- 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
- 112 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yifei Huang, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Bin Wu, Professor, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358092
- Sponsor's protocol ID
- ZSSYXHNK2401
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
PubMed 35120736Kaplan DE, Ripoll C, Thiele M, Fortune BE, Simonetto DA, Garcia-Tsao G, Bosch J. AASLD Practice Guidance on risk stratification and management of portal hypertension and varices in cirrhosis. Hepatology. 2024 May 1;79(5):1180-1211. doi: 10.1097/HEP.0000000000000647. Epub 2023 Oct 23. No abstract available.
PubMed 37870298Dajti E, Ravaioli F, Zykus R, Rautou PE, Elkrief L, Grgurevic I, Stefanescu H, Hirooka M, Fraquelli M, Rosselli M, Chang PEJ, Piscaglia F, Reiberger T, Llop E, Mueller S, Marasco G, Berzigotti A, Colli A, Festi D, Colecchia A; Spleen Stiffness-IPD-MA Study Group. Accuracy of spleen stiffness measurement for the diagnosis of clinically significant portal hypertension in patients with compensated advanced chronic liver disease: a systematic review and individual patient data meta-analysis. Lancet Gastroenterol Hepatol. 2023 Sep;8(9):816-828. doi: 10.1016/S2468-1253(23)00150-4. Epub 2023 Jul 18.
PubMed 37478880
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spleen Stiffness and Liver Stiffness Measured by Two-dimensional Shear Wave Elastography for Assessment of Cirrhosis and Portal Hypertension
- ClinicalTrials.gov ID
- NCT06358092
- Acronym / sponsor ID
- ZSSYXHNK2401
- Conditions
- Cirrhosis, Liver, Portal Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 10 Apr 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.
Exploring and establishing new non-invasive risk stratification techniques for portal hypertension based on E imaging technology for measuring liver and spleen stiffness is an urgent need in this field of research.
Detailed description
Portal hypertension is an important risk factor affecting the clinical prognosis of patients with liver cirrhosis. According to clinical practice guidelines, risk stratification based on portal vein pressure levels is crucial for predicting the prognosis of patients with cirrhotic portal hypertension, and it is one of the most important aspects in the diagnosis and treatment chain of end-stage liver diseases such as cirrhosis. The most reliable method for assessing portal vein pressure in patients with cirrhosis is the measurement of hepatic venous pressure gradient (HVPG). This is achieved by inserting a catheter into the hepatic vein via jugular vein puncture, measuring the free and wedged pressures, and calculating the difference to obtain HVPG. HVPG provides important information regarding treatment response, complication risks, and long-term prognosis for patients with cirrhotic portal hypertension: HVPG ≥ 10mmHg indicates an increased risk of varices, decompensation events, and hepatocellular carcinoma in compensated cirrhosis patients, HVPG ≥ 12mmHg is a high-risk factor for variceal bleeding, HVPG ≥ 16mmHg suggests an increased risk of death in patients with cirrhotic portal hypertension, and HVPG ≥ 20mmHg indicates higher failure rates of hemostatic treatment and increased mortality risk in patients with acute variceal bleeding. However, there are some issues with measuring HVPG, including invasiveness, technical requirements, and high costs, which limit its clinical application. The development of non-invasive assessment techniques for portal hypertension in cirrhosis has always been a hotspot and difficulty in this field.
In recent years, with the rapid development of ultrasound elastography technology, it has also been widely used in the field of liver diseases. Transient elastography, point shear wave elastography, and two-dimensional shear wave elastography (referred to as E imaging) all have important value in the non-invasive assessment of portal hypertension in cirrhosis. Ultrasound elastography, due to its advantages of non-invasiveness, rapidity, ease of operation, repeatability, safety, and ease of follow-up monitoring, is of great significance in risk stratification, precise management, and efficacy evaluation of portal hypertension in cirrhosis. Although liver stiffness has been applied in the diagnosis, treatment, and prognosis assessment of cirrhotic portal hypertension, transient elastography is still the main ultrasound elastography technique used clinically, and there are relatively few original studies related to spleen stiffness. Therefore, there is currently a lack of high-level clinical evidence based on E imaging technology for evaluating portal hypertension in cirrhosis in China, as well as a lack of original research on spleen stiffness assessment in cirrhotic portal hypertension.
In summary, exploring and establishing new non-invasive risk stratification techniques for portal hypertension based on E imaging technology for measuring liver and spleen stiffness is an urgent need in this field of research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | Diagnostic Test: Hepatic venous pressure gradient, Diagnostic Test: Two-Dimensional Shear Wave ElastographyTo explore the cut-off value of LSM and SSM by 2D-SWE for assessment of CSPH in cirrhosis. |
| Validation cohort | – | Diagnostic Test: Hepatic venous pressure gradient, Diagnostic Test: Two-Dimensional Shear Wave ElastographyTo validate the cut-off value of LSM and SSM by 2D-SWE for assessment of CSPH in cirrhosis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cirrhosis and portal hypertension
Key inclusion criteria (5 listed)
- Age: 18-75 years old;
- Clinical diagnosis of liver cirrhosis (confirmed by pathological biopsy, imaging findings, or occurrence of relevant complications);
- Scheduled for hepatic venous pressure gradient (HVPG) examination;
- Planned to undergo measurement of liver and spleen stiffness using E imaging technology;
- Voluntary signing of informed consent form.
Key exclusion criteria (6 listed)
- Contraindications to hepatic venous pressure gradient examination;
- Liver intervention surgery scheduled between E imaging examination and HVPG examination;
- Interval between E imaging examination and HVPG examination exceeds 14 days;
- Presence of liver cancer;
- Concurrent active, severe, life-threatening diseases;
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 |
|---|---|---|
| Hepatic venous pressure gradientHVPG is a measurement used to assess portal hypertension, a condition characterized by increased blood pressure in the portal vein, which carries blood from the digestive organs to the liver. HVPG measurement involves inserting a catheter into the hepatic vein via jugular vein puncture to directly measure the pressure within the liver. By comparing the pressure in the hepatic vein with that in the portal vein, HVPG provides valuable information about the severity of portal hypertension and helps in predicting clinical outcomes in patients with liver cirrhosis and related conditions. HVPG measurements are crucial in guiding treatment decisions, assessing treatment response, and predicting the risk of complications such as variceal bleeding and liver failure. | Diagnostic test | Training cohort, Validation cohort |
| Two-Dimensional Shear Wave Elastography2D-SWE is a non-invasive imaging technique used to assess tissue stiffness, particularly in the liver. This technology utilizes ultrasound to generate shear waves within the tissue being examined. By measuring the speed of these shear waves as they propagate through the tissue, 2D-SWE can provide quantitative information about tissue elasticity or stiffness. In the context of liver disease, including cirrhosis and fibrosis, 2D-SWE is valuable for evaluating the degree of liver stiffness, which correlates with the severity of liver fibrosis. This information aids in diagnosis, staging, and monitoring of liver diseases, allowing for early detection of complications and assessment of treatment response. Compared to traditional biopsy-based methods, 2D-SWE offers the advantage of being non-invasive, rapid, and repeatable, making it a preferred modality for assessing liver stiffness in clinical practice. | Diagnostic test | Training cohort, Validation cohort |
Primary outcome
the diagnostic performance of liver and spleen stiffness by E imaging technology for clinically significant portal hypertension
Time frame: 1 year
Using HVPG as the gold standard, the diagnostic performance of measuring liver and spleen stiffness based on E imaging technology for clinically significant portal hypertension.
2 secondary outcomes
the diagnostic performance of microvessel imaging of hepatic microcirculation by E imaging technology for clinically significant portal hypertension
Time frame: 1 year
the difference among left, middle and right hepatic venous pressure gradient
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Results publication: PubMed 35120736de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
- Results publication: PubMed 37870298Kaplan DE, Ripoll C, Thiele M, Fortune BE, Simonetto DA, Garcia-Tsao G, Bosch J. AASLD Practice Guidance on risk stratification and management of portal hypertension and varices in cirrhosis. Hepatology. 2024 May 1;79(5):1180-1211. doi: 10.1097/HEP.0000000000000647. Epub 2023 Oct 23. No abstract available.
- Results publication: PubMed 37478880Dajti E, Ravaioli F, Zykus R, Rautou PE, Elkrief L, Grgurevic I, Stefanescu H, Hirooka M, Fraquelli M, Rosselli M, Chang PEJ, Piscaglia F, Reiberger T, Llop E, Mueller S, Marasco G, Berzigotti A, Colli A, Festi D, Colecchia A; Spleen Stiffness-IPD-MA Study Group. Accuracy of spleen stiffness measurement for the diagnosis of clinically significant portal hypertension in patients with compensated advanced chronic liver disease: a systematic review and individual patient data meta-analysis. Lancet Gastroenterol Hepatol. 2023 Sep;8(9):816-828. doi: 10.1016/S2468-1253(23)00150-4. Epub 2023 Jul 18.
- 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. This study is not recruiting at the moment.
Yifei Huang, Doctor contact
Bin Wu, Professor principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver and Portal Hypertension, run by Third Affiliated Hospital, Sun Yat-Sen University.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yifei Huang, Doctor (huangyf1995@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the diagnostic performance of liver and spleen stiffness by E imaging technology for clinically significant portal hypertension (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06358092, which also lists 3 linked publications.
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 10 Apr 2024.