NCT07753577Not yet recruiting
Clinical Trial to Evaluate the Effectiveness of Liver Shear Wave Quantization Detector Spleen Stiffness Value in the Diagnosis of Esophageal Varices
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 246 (estimated)
- First submitted
- 24 Jul 2026
- Start date
- 20 Aug 2026
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- Beijing Friendship Hospital
- NCT number
- NCT07753577
What you commit to
- Study type: Observational
- Planned participants: 246
- From 20 Aug 2026 to the primary completion date, 30 Oct 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- after liver transplantation or TIPS;
Other illness
- complicated with important organ diseases (except liver) or serious systemic diseases (such as malignant tumors and HIV);
- 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;
- Other conditions judged by the investigators as not suitable for participating in the study.
Lab values
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 U/L;
- complicated with jaundice (serum total bilirubin ≥50 μmol/L);
Other
- after splenectomy, splenic embolization or other portasystemic shunts;
- patients with moderate-to-large amount of ascites;
- unhealed wounds or scars in the left abdomen were not suitable for ultrasound examination;
- pregnant women;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
This page is information, not medical advice. Discuss any trial with your doctor.