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.

Development and Validation of a Comprehensive Management Service Package for Older Adults With Multimorbidity

This study aims to test a new comprehensive management service package for older adults with two or more chronic conditions (multimorbidity). The package includes digital health tools, personalized guidance, and long-term management support. Researchers will compare the service package with usual care to see whether it reduces hospital readmissions, improves quality of life, and supports daily functioning. About 394 participants will be randomly assigned to either the service package group or the usual care group. Participants will be followed for 6 months to measure health outcomes, treatment adherence, and safety.

Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease

Chronic liver diseases represent a major public health problem and are responsible for more than 150,000 deaths in Europe each year. These diseases are accompanied by symptoms that profoundly alter the quality of life and mainly affect people of working age, leading to a major economic impact. Coagulation disorders, inflammation and vascular alterations are associated with chronic liver diseases but their role in the onset and/or progression of liver diseases is still not fully understood. A better understanding of chronic liver diseases and in particular of the factors that play a role in the onset and progression of these diseases would improve patient management and therefore have a positive impact on individuals, but also on the healthcare system and the economy.