Clinical Trial to Evaluate the Effectiveness of Liver Shear Wave Quantization Detector Spleen Stiffness Value in the Diagnosis of Esophageal Varices

Обзор

Esophageal variceal bleeding is one of the serious and life-threatening complications of chronic liver disease (CLD). Studies have shown that the prevalence of esophageal varices (EV) in patients with liver cirrhosis is about 50%-60%. The annual incidence of variceal bleeding in these patients is about 5%-15%, and the rebleeding rate can reach 30%-40% within 6 weeks after the first bleeding. The 6-week mortality related to variceal bleeding is as high as 10%-20%, which seriously threatens the life safety of patients with liver disease. Clinically, esophagogastroduodenoscopy (EGD) is the gold standard for the diagnosis and grading of esophageal varices. However, EGD is an invasive examination, which has certain application limitations such as related complications and high cost, which limits the promotion and application of this technology. Therefore, there is an urgent need for an accurate, convenient and non-invasive method for esophageal varices. To address this clinical pain point, Baveno VII guidelines state that spleen stiffness measurement (SSM) based on vibration-controlled transient elastography (TE) can be used as a noninvasive marker to predict esophageal varices (EV). Several studies have shown that SSM measured by TE has good diagnostic performance in relation to the occurrence and severity of esophageal varices. A study involving 191 patients with liver disease showed that spleen stiffness was significantly higher in patients with varices than in those without varices (63.69 vs 47.78 kPa, P\<0.0001), and the AUC of SSM for the diagnosis of EV was 0.74. In another study involving 260 patients with chronic liver disease, the AUC of SSM was 0.728 (95% CI: 0.665-0.791) for EV and 0.780 (95% CI: 0.714-0.846) for high-risk varix (HRV). The above results indicate that SSM has good clinical value in the prediction of EV. Pro9000X, a liver function shear wave quantization detector based on vibration control TE, has been developed by Wuxi Hisiel Medical Technology Co., LTD. The device integrates ultrasound image positioning and TE function, aiming to achieve rapid, quantitative and non-invasive detection of liver stiffness measurement (LSM) and SSM. The results of EGD examination were used as the gold standard to evaluate the diagnostic performance of the spleen stiffness value detected by Pro9000X in patients with chronic liver disease, and the main evaluation indicators were the sensitivity and specificity of EV diagnosis. Secondary evaluation included AUROC, optimal cut-off value and diagnostic value of high-risk EV.

Первичные конечные точки

• The results of esophagogastric duodenoscopy (EGD) were used as the gold standard to evaluate the diagnostic performance of spleen stiffness value detected by liver function shear wave quantization detector Pro9000X for esophageal varices (EV) in patients [Срок оценки: day 1: Screening period visit（Sign the informed consent form, meet the inclusion and exclusion criteria, et al） day 2-day 30: Trial visit during the period of experimentation (EGD and Pro9000X Spleen Hardness Examination) day 31: Pre-group visitation]

Критерии участия

Критерии включения

• Age over 18 years old, male or female;
• patients with clinically diagnosed chronic liver disease, including hepatitis C virus (HCV) infection, hepatitis B virus (HBV) infection, fatty liver disease, autoimmune liver disease, and alcoholic liver disease \*;
• Liver stiffness measurement (LSM) ≥10kPa during screening or within one month before screening \[4\];
• able to communicate well with the investigators, understand and comply with the requirements of the study;
• Informed consent was signed voluntarily.

Критерии исключения

• alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 U/L;
• complicated with jaundice (serum total bilirubin ≥50 μmol/L);
• complicated with important organ diseases (except liver) or serious systemic diseases (such as malignant tumors and HIV);
• after liver transplantation or TIPS;
• after splenectomy, splenic embolization or other portasystemic shunts;
• patients with moderate-to-large amount of ascites;
• unstable condition in the acute stage of esophageal variceal bleeding;
• combined with liver malignant tumors;
• patients with non-cirrhotic portal hypertension, Budd-Chiari syndrome and other hepatic vascular diseases; Acute or chronic portal vein thrombosis;
• unhealed wounds or scars in the left abdomen were not suitable for ultrasound examination;
• pregnant women;
• Other conditions judged by the investigators as not suitable for participating in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07753577 · 2026-P1-MD-011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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