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

NCT07151885 | Recruiting

• 1 other identifier: 2025-MS-306
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Liver Cirrhosis; Esophageal and Gastric Varices

Keywords

Liver Cirrhosis; Esophageal and Gastric Varices; Subharmonic Aided Pressure Estimation

Outcome Measures

Primary Outcomes (6)

• HV-PV (dB)

  The difference in the average harmonic signal between the hepatic vein and the portal vein

  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.

  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.

  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).

  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

  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

  The one-year period from enrollment to the end of the group

Study Arms (1)

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.

Diagnostic Test: SHAPE

Interventions

SHAPE DIAGNOSTIC_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.

SHAPE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 35120736 BACKGROUND

• Wang 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.

  PMID: 33039403 BACKGROUND

• Ding 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.

  PMID: 26212020 BACKGROUND

• Vorobioff 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.

  PMID: 24913395 BACKGROUND

• Stefanescu 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.

  PMID: 31444849 BACKGROUND

• 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. PLoS One. 2021 Dec 2;16(12):e0260774. doi: 10.1371/journal.pone.0260774. eCollection 2021.

  PMID: 34855845 BACKGROUND

• Diaz-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.

  PMID: 35757384 BACKGROUND

• Liang 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.

  PMID: 35911970 BACKGROUND

Related Links

• Related Info
• 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.
• 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.
• Vorobioff J D, Groszmann R J. Prevention of portal hypertension: From variceal development to clinical Decompensation\[J\]. Hepatology, 2015, 61(1): 375～381.
• \] 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.

MeSH Terms

Conditions

Liver Cirrhosis; Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Hypertension, Portal

Central Study Contacts

Dezhi Zhang, doctorate

CONTACT

0431-88782190; dezhi@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The SHAPE operator and the analyst, the LSM operator, and the gastroscopy operator blinded each other (unaware of each other's results and clinical data), and the SHAPE images were independently analyzed by two ultrasound physicians.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PI

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 5, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)