Liver CirrhosisNCT07151885
The Diagnostic Value of Subharmonic Imaging Technology Combined With Liver Stiffness and Platelet Count for High-risk Esophageal and Gastric Varices in Patients With Liver Cirrhosis
A study testing SHAPE in people with Liver Cirrhosis and Esophageal and Gastric Varices, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
To evaluate the diagnostic value of the combined model of subharmonic-assisted pressure estimation (SHAPE), liver stiffness (LSM), and platelet count (PLT) for high-risk esophageal and gastric varices (HRV) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Esophageal and Gastric Varices
- What is being tested?
- SHAPE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2025to 31 Jul 2028
- Phase
- Interventional
- 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
Who may be able to join
- ① Be at least 18 years old② Clinically diagnosed as liver cirrhosis (based on medical history, physical signs, laboratory tests, imaging or liver biopsy)③ Underwent a gastroscopy④ The informed consent form has been signed
Who cannot join
- ① Previous EV bleeding or having received TIPS/ endoscopic treatment.② History of concurrent liver cancer, portal vein thrombosis, and splenectomy.③ Having used drugs that affect platelet count, liver function or coagulation function in the body within one week, and having a recent history of blood product infusion.
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 Hospital of Jilin University
Changchun, Jilin, 130021
dezhi zhang, MD, dezhi@jlu.edu.cn
About this study
To evaluate the diagnostic value of the combined model of subharmonic-assisted pressure estimation (SHAPE), liver stiffness (LSM), and platelet count (PLT) for high-risk esophageal and gastric varices (HRV)
- Conditions
- Liver Cirrhosis, Esophageal and Gastric Varices
- Being tested
- SHAPE
- Keywords
- Liver Cirrhosis, Esophageal and Gastric Varices, Subharmonic Aided Pressure Estimation
- Medical subject headings
- Liver Cirrhosis, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHAPEDiagnostic test
Use an ultrasound probe to scan the liver to locate the portal vein and hepatic vein. In the angiography mode, the portal vein and hepatic vein of the same depth were selected for measurement respectively. Ultrasound contrast agent was injected through the elbow vein to observe the changes of sub-harmonic signals in the portal vein and hepatic vein. Collect the sub-harmonic signal data of the portal vein and hepatic vein, and calculate the difference between the two, that is, the SHAPE gradient.
| Study group | Role | What they receive |
|---|---|---|
| SHAPE | Experimental | Use an ultrasound probe to scan the liver to locate the portal vein and hepatic vein. In the angiography mode, the portal vein and hepatic vein of the same depth were selected for measurement respectively. Ultrasound contrast agent was injected through the elbow vein to observe the changes of sub-harmonic signals in the portal vein and hepatic vein. Collect the sub-harmonic signal data of the portal vein and hepatic vein, and calculate the difference between the two, that is, the SHAPE gradient. Receives: Diagnostic Test: SHAPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
HV-PV (dB)
The difference in the average harmonic signal between the hepatic vein and the portal vein
Measured: Within two weeks of admission
Measurement of liver stiffness（kPa）
The patient lies on their back, with their right hand placed behind their head. The right upper limb is fully abducted to expose the intercostal Spaces in the right lobe of the liver. The area usually enclosed by the horizontal line of the xiphoid process, the midline of the right axilla and the lower edge of the rib is taken as the testing area. The probe is vertically and closely attached to the skin, and the measurement position is selected in the intercostal space.
Measured: Within two weeks of admission
blood platelet count（×10⁹／L）
The peripheral blood of the patient was tested by a conventional blood analyzer to obtain the platelet count.
Measured: Within two weeks of admission
sensitivity and specificity
The sensitivity measures the ability of the model to correctly identify patients with HRV (i.e., the true positive rate), and the specificity measures the ability of the model to correctly exclude patients without HRV (i.e., the true negative rate).
Measured: The one-year period from enrollment to the end of the group
Positive predictive value (PPV) and negative predictive value (NPV)
PPV represents the probability that patients identified as high-risk by the model actually have HRV, while NPV represents the probability that patients identified as low-risk by the model do not actually have HRV
Measured: The one-year period from enrollment to the end of the group
AUC
Comprehensively reflect the overall discriminative ability of the model under different thresholds
Measured: The one-year period from enrollment to the end of the group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start31 Aug 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study proposes for the first time a multimodal model integrating SHAPE, LSM and PLT, aiming to overcome the shortcomings of traditional tools, improve the prediction accuracy of high-risk EGV, and provide a new path for optimizing non-invasive screening strategies.
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dezhi Zhang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151885
- Sponsor's protocol ID
- 2025-MS-306
- Status last verified
- Jul 2025
- First submitted
- 26 Aug 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- 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 35120736Wang H, Wen B, Chang X, Wu Q, Wen W, Zhou F, Guo Y, Ji Y, Gu Y, Lai Q, He Q, Li J, Chen J, Hou J. Baveno VI criteria and spleen stiffness measurement rule out high-risk varices in virally suppressed HBV-related cirrhosis. J Hepatol. 2021 Mar;74(3):584-592. doi: 10.1016/j.jhep.2020.09.034. Epub 2020 Oct 8.
PubMed 33039403Ding NS, Nguyen T, Iser DM, Hong T, Flanagan E, Wong A, Luiz L, Tan JY, Fulforth J, Holmes J, Ryan M, Bell SJ, Desmond PV, Roberts SK, Lubel J, Kemp W, Thompson AJ. Liver stiffness plus platelet count can be used to exclude high-risk oesophageal varices. Liver Int. 2016 Feb;36(2):240-5. doi: 10.1111/liv.12916. Epub 2015 Sep 6.
PubMed 26212020Vorobioff JD, Groszmann RJ. Prevention of portal hypertension: from variceal development to clinical decompensation. Hepatology. 2015 Jan;61(1):375-81. doi: 10.1002/hep.27249. Epub 2014 Sep 26.
PubMed 24913395Stefanescu H, Marasco G, Cales P, Fraquelli M, Rosselli M, Ganne-Carrie N, de Ledinghen V, Ravaioli F, Colecchia A, Rusu C, Andreone P, Mazzella G, Festi D. A novel spleen-dedicated stiffness measurement by FibroScan(R) improves the screening of high-risk oesophageal varices. Liver Int. 2020 Jan;40(1):175-185. doi: 10.1111/liv.14228. Epub 2019 Sep 11.
PubMed 31444849Yu S, Chen W, Jiang Z. Platelet count/spleen volume ratio has a good predictive value for esophageal varices in patients with hepatitis B liver cirrhosis. PLoS One. 2021 Dec 2;16(12):e0260774. doi: 10.1371/journal.pone.0260774. eCollection 2021.
PubMed 34855845Diaz-Soto MP, Garcia-Tsao G. Management of varices and variceal hemorrhage in liver cirrhosis: a recent update. Ther Adv Gastroenterol. 2022 Jun 20;15:17562848221101712. doi: 10.1177/17562848221101712. eCollection 2022.
PubMed 35757384Liang H, Si H, Liu M, Yuan L, Ma R, Zhang G, Yang J, Mo Z, Zhao Q. Non-Invasive Prediction Models for Esophageal Varices and Red Signs in Patients With Hepatitis B Virus-Related Liver Cirrhosis. Front Mol Biosci. 2022 Jul 12;9:930762. doi: 10.3389/fmolb.2022.930762. eCollection 2022.
PubMed 35911970
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Subharmonic Imaging Technology Combined With Liver Stiffness and Platelet Count for High-risk Esophageal and Gastric Varices in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT07151885
- Acronym / sponsor ID
- 2025-MS-306
- Conditions
- Liver Cirrhosis, Esophageal and Gastric Varices
- Keywords
- Liver Cirrhosis, Esophageal and Gastric Varices, Subharmonic Aided Pressure Estimation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 3 Sep 2025 (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.
To evaluate the diagnostic value of the combined model of subharmonic-assisted pressure estimation (SHAPE), liver stiffness (LSM), and platelet count (PLT) for high-risk esophageal and gastric varices (HRV)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study proposes for the first time a multimodal model integrating SHAPE, LSM and PLT, aiming to overcome the shortcomings of traditional tools, improve the prediction accuracy of high-risk EGV, and provide a new path for optimizing non-invasive screening strategies.
| Arm | Type | Receives |
|---|---|---|
| SHAPE | Experimental | Diagnostic Test: SHAPEUse an ultrasound probe to scan the liver to locate the portal vein and hepatic vein. In the angiography mode, the portal vein and hepatic vein of the same depth were selected for measurement respectively. Ultrasound contrast agent was injected through the elbow vein to observe the changes of sub-harmonic signals in the portal vein and hepatic vein. Collect the sub-harmonic signal data of the portal vein and hepatic vein, and calculate the difference between the two, that is, the SHAPE gradient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ① Be at least 18 years old② Clinically diagnosed as liver cirrhosis (based on medical history, physical signs, laboratory tests, imaging or liver biopsy)③ Underwent a gastroscopy④ The informed consent form has been signed
Key exclusion criteria (1 listed)
- ① Previous EV bleeding or having received TIPS/ endoscopic treatment.② History of concurrent liver cancer, portal vein thrombosis, and splenectomy.③ Having used drugs that affect platelet count, liver function or coagulation function in the body within one week, and having a recent history of blood product infusion.
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 |
|---|---|---|
| SHAPEUse an ultrasound probe to scan the liver to locate the portal vein and hepatic vein. In the angiography mode, the portal vein and hepatic vein of the same depth were selected for measurement respectively. Ultrasound contrast agent was injected through the elbow vein to observe the changes of sub-harmonic signals in the portal vein and hepatic vein. Collect the sub-harmonic signal data of the portal vein and hepatic vein, and calculate the difference between the two, that is, the SHAPE gradient. | Diagnostic test | SHAPE |
Primary outcome
HV-PV (dB)
Time frame: Within two weeks of admission
The difference in the average harmonic signal between the hepatic vein and the portal vein
Measurement of liver stiffness（kPa）
Time frame: Within two weeks of admission
The patient lies on their back, with their right hand placed behind their head. The right upper limb is fully abducted to expose the intercostal Spaces in the right lobe of the liver. The area usually enclosed by the horizontal line of the xiphoid process, the midline of the right axilla and the lower edge of the rib is taken as the testing area. The probe is vertically and closely attached to the skin, and the measurement position is selected in the intercostal space.
blood platelet count（×10⁹／L）
Time frame: Within two weeks of admission
The peripheral blood of the patient was tested by a conventional blood analyzer to obtain the platelet count.
sensitivity and specificity
Time frame: The one-year period from enrollment to the end of the group
The sensitivity measures the ability of the model to correctly identify patients with HRV (i.e., the true positive rate), and the specificity measures the ability of the model to correctly exclude patients without HRV (i.e., the true negative rate).
Positive predictive value (PPV) and negative predictive value (NPV)
Time frame: The one-year period from enrollment to the end of the group
PPV represents the probability that patients identified as high-risk by the model actually have HRV, while NPV represents the probability that patients identified as low-risk by the model do not actually have HRV
AUC
Time frame: The one-year period from enrollment to the end of the group
Comprehensively reflect the overall discriminative ability of the model under different thresholds
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 5 May 2026.
- Background: 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.
- Background: PubMed 33039403Wang H, Wen B, Chang X, Wu Q, Wen W, Zhou F, Guo Y, Ji Y, Gu Y, Lai Q, He Q, Li J, Chen J, Hou J. Baveno VI criteria and spleen stiffness measurement rule out high-risk varices in virally suppressed HBV-related cirrhosis. J Hepatol. 2021 Mar;74(3):584-592. doi: 10.1016/j.jhep.2020.09.034. Epub 2020 Oct 8.
- Background: PubMed 26212020Ding NS, Nguyen T, Iser DM, Hong T, Flanagan E, Wong A, Luiz L, Tan JY, Fulforth J, Holmes J, Ryan M, Bell SJ, Desmond PV, Roberts SK, Lubel J, Kemp W, Thompson AJ. Liver stiffness plus platelet count can be used to exclude high-risk oesophageal varices. Liver Int. 2016 Feb;36(2):240-5. doi: 10.1111/liv.12916. Epub 2015 Sep 6.
- Background: PubMed 24913395Vorobioff JD, Groszmann RJ. Prevention of portal hypertension: from variceal development to clinical decompensation. Hepatology. 2015 Jan;61(1):375-81. doi: 10.1002/hep.27249. Epub 2014 Sep 26.
- Background: PubMed 31444849Stefanescu H, Marasco G, Cales P, Fraquelli M, Rosselli M, Ganne-Carrie N, de Ledinghen V, Ravaioli F, Colecchia A, Rusu C, Andreone P, Mazzella G, Festi D. A novel spleen-dedicated stiffness measurement by FibroScan(R) improves the screening of high-risk oesophageal varices. Liver Int. 2020 Jan;40(1):175-185. doi: 10.1111/liv.14228. Epub 2019 Sep 11.
- Background: PubMed 34855845Yu S, Chen W, Jiang Z. Platelet count/spleen volume ratio has a good predictive value for esophageal varices in patients with hepatitis B liver cirrhosis. PLoS One. 2021 Dec 2;16(12):e0260774. doi: 10.1371/journal.pone.0260774. eCollection 2021.
- Background: PubMed 35757384Diaz-Soto MP, Garcia-Tsao G. Management of varices and variceal hemorrhage in liver cirrhosis: a recent update. Ther Adv Gastroenterol. 2022 Jun 20;15:17562848221101712. doi: 10.1177/17562848221101712. eCollection 2022.
- Background: PubMed 35911970Liang H, Si H, Liu M, Yuan L, Ma R, Zhang G, Yang J, Mo Z, Zhao Q. Non-Invasive Prediction Models for Esophageal Varices and Red Signs in Patients With Hepatitis B Virus-Related Liver Cirrhosis. Front Mol Biosci. 2022 Jul 12;9:930762. doi: 10.3389/fmolb.2022.930762. eCollection 2022.
- Related InfoLink provided by the sponsor.
- Liang H, Si H, Liu M, et al. Non-invasive prediction models for esophageal varices and red signs in patients with hepatitis B virus-related liver Cirrhosis\[J\]. Frontiers in Molecular Biosciences, 2022, 9: 930762.Link provided by the sponsor.
- Yu S, Chen W, Jiang Z. Platelet count/spleen volume ratio has a good predictive value for esophageal varices in patients with hepatitis B liver Cirrhosis\[J\]. PLOS One, 2021, 16(12): e0260774.Link provided by the sponsor.
- Vorobioff J D, Groszmann R J. Prevention of portal hypertension: From variceal development to clinical Decompensation\[J\]. Hepatology, 2015, 61(1): 375～381.Link provided by the sponsor.
- \] De Franchis R, Bosch J, Garcia-Tsao G, et al. Baveno VII - renewing consensus in portal Hypertension\[J\]. Journal of Hepatology, 2022, 76(4): 959～974.Link provided by the sponsor.
- 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?
A study testing SHAPE in people with Liver Cirrhosis and Esophageal and Gastric Varices, run by The First Hospital of Jilin 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 1 inclusion and 1 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 5 May 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 Dezhi Zhang, doctorate (0431-88782190, dezhi@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HV-PV (dB) (time frame: Within two weeks of admission). The study lists 6 primary outcomes in all. 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 NCT07151885, which also lists 8 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 5 May 2026.