NCT07450651Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
Background: Chronic 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. Objective: This 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. Methods: This 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. Outcomes: The 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. Significance: If 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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 10 Feb 2026
- Start date
- Feb 2026
- Primary completion date
- Oct 2026
- Lead sponsor
- Beijing Friendship Hospital
- Diseases
- Hepatitis B, High blood pressure
- NCT number
- NCT07450651
What you commit to
- Study type: Observational
- Planned participants: 150
- From Feb 2026 to the primary completion date, 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
- Previous portosystemic shunt treatment or splenectomy.
Other illness
- Co-existing chronic liver diseases.
- A history of treatment for upper gastrointestinal varices that affects the assessment.
- Co-existing malignancies.
Other
- Severe hepatic or splenic iron deposition.
- Decompensated cirrhosis.
Who the study is looking for
- Age ≥ 18 years.
- Clinically diagnosed with chronic hepatitis B cirrhosis
- Acceptance of upper gastrointestinal endoscopy screening or evaluation.
- Abdominal MRI examination with IVIM sequence within 6 months prior to endoscopy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.