Recruiting NCT07151885
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHAPE.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis, Esophageal and Gastric Varices. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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)
Interventions
- Diagnostic test 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.
Primary outcome measures
- HV-PV (dB) [Time frame: Within two weeks of admission]
- Measurement of liver stiffness（kPa） [Time frame: Within two weeks of admission]
- blood platelet count（×10⁹／L） [Time frame: Within two weeks of admission]
- sensitivity and specificity [Time frame: The one-year period from enrollment to the end of the group]
- Positive predictive value (PPV) and negative predictive value (NPV) [Time frame: The one-year period from enrollment to the end of the group]
- AUC [Time frame: The one-year period from enrollment to the end of the group]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- The First Hospital of Jilin University — Changchun
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. PMID 35120736
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07151885 · 2025-MS-306