[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatitis-b-virus-related-cirrhosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatitis-b-virus-related-cirrhosis":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100627593","hepatic-and-splenic-microcirculatory-perfusion-for-ruling-out-high-risk-varices-in-patients-with-hepatitis-b-related-cirrhosis-100627593",false,"NCT07450651","Hepatic and Splenic Microcirculatory Perfusion for Ruling Out High-Risk Varices in Patients With Hepatitis B-Related Cirrhosis","Development of a Hepato-Splenic Microcirculatory Perfusion Model Using IVIM MRI to Rule Out High-Risk Varices in Patients With Compensated Hepatitis B-Related Cirrhosis","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Clinically diagnosed with chronic hepatitis B cirrhosis\n3. Acceptance of upper gastrointestinal endoscopy screening or evaluation.\n4. Abdominal MRI examination with IVIM sequence within 6 months prior to endoscopy.\n\nExclusion Criteria:\n\n1. Co-existing chronic liver diseases.\n2. Previous portosystemic shunt treatment or splenectomy.\n3. A history of treatment for upper gastrointestinal varices that affects the assessment.\n4. Severe hepatic or splenic iron deposition.\n5. Decompensated cirrhosis.\n6. Co-existing malignancies.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","OBSERVATIONAL","Background:\n\nChronic hepatitis B (CHB)-related cirrhosis is a common cause of portal hypertension, which leads to the development of gastroesophageal varices (EGVs). High-risk varices (HRV) are associated with a higher risk of bleeding and require timely interventions. Endoscopy is the gold standard for diagnosing HRV but is invasive and not suitable for routine screening in large populations.\n\nObjective:\n\nThis study aims to develop a noninvasive model based on hepatic and splenic microcirculatory perfusion parameters derived from intravoxel incoherent motion (IVIM) magnetic resonance imaging (MRI) to predict and rule out HRV in patients with compensated CHB-related cirrhosis receiving antiviral therapy.\n\nMethods:\n\nThis observational, retrospective study will include patients with compensated CHB-related cirrhosis who have undergone both esophagogastroduodenoscopy (EGD) and IVIM MRI. Microcirculatory perfusion parameters will be extracted from IVIM images using a biexponential model, and their ability to predict HRV will be assessed.\n\nOutcomes:\n\nThe study will validate the performance of the Hepato-Splenic Microcirculatory Perfusion Model (HSMP) in ruling out HRV compared to conventional noninvasive tests like APRI, FIB-4, and LSM. The model's diagnostic accuracy will be evaluated with a focus on reducing unnecessary endoscopic procedures.\n\nSignificance:\n\nIf successful, this model could reduce the need for invasive endoscopy and improve the management of cirrhosis patients by providing a safer and more accessible screening tool for HRV.",[24,25,26],"Hepatitis B Virus Related Cirrhosis","Portal Hypertension Related to Cirrhosis","Esophagogastric Varices",[28,29,30,31,32,33,34],"Intravoxel incoherent motion","Hepatic microcirculation","Splenic microcirculation","High-risk varices","Baveno VI criteria","FIB-4","Liver stiffness measurement","NOT_YET_RECRUITING","2026-03-01",{"date":38,"type":39},"2026-03-05","ACTUAL",{"date":41,"type":20},"2026-02",{"date":43,"type":20},"2026-10",{"name":45,"class":46},"Beijing Friendship Hospital","OTHER"]