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
NCT ID: NCT07151885
Last Updated: 2025-09-03
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
380 participants
INTERVENTIONAL
2025-08-31
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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SHAPE
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
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.
Interventions
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SHAPE
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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The First Hospital of Jilin University
OTHER
Responsible Party
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
Diaz-Soto MP, Garcia-Tsao G. Management of varices and variceal hemorrhage in liver cirrhosis: a recent update. Therap Adv Gastroenterol. 2022 Jun 20;15:17562848221101712. doi: 10.1177/17562848221101712. eCollection 2022.
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.
Related Links
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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.
Other Identifiers
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2025-MS-306
Identifier Type: -
Identifier Source: org_study_id
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