Clinical Research Directory

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

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.

The Value of Spleen Stiffness Measurement in Patients With PBC

Recent evidence suggests that combining liver stiffness measurement (LSM) with spleen stiffness measurement (SSM) significantly improves risk stratification in patients with PBC. In a study the addition of spleen stiffness to liver stiffness enhanced the prediction of liver decompensation, providing a more precise evaluation of portal hypertension. Furthermore, when combined with platelet count, this approach effectively identified patients with a low probability of harboring HRVs. This could allow clinicians to safely avoid unnecessary endoscopic procedures in selected patients, improving patient comfort and reducing healthcare costs. Therefore, our patients participating in this trial will undergo follow up (every 6 months) as per Standard of care. This includes a blood draw, FibroScan and Ultrasound. Together with this, 2 questionnaires will be completed (not as per SOC) and during the FibroScan, a spleen stiffness measurement will be performed.

Effect of Malnutrition on Liver and Spleen Stiffness in Children

This prospective observational study aims to evaluate the effect of malnutrition on liver and spleen stiffness in children using shear wave elastography. Two groups of participants will be enrolled: children diagnosed with malnutrition and age-matched healthy controls. Organ stiffness measurements will be compared between the two groups to assess the impact of malnutrition on liver and spleen tissue properties.