Hepatic and Splenic Microcirculatory Perfusion for Ruling Out High-Risk Varices in Patients With Hepatitis B-Related Cirrhosis

NCT07450651 | Not Yet Recruiting

• 1 other identifier: BFHHZS20250369
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatitis B Virus Related Cirrhosis; Portal Hypertension Related to Cirrhosis; Esophagogastric Varices

Keywords

Intravoxel incoherent motion; Hepatic microcirculation; Splenic microcirculation; High-risk varices; Baveno VI criteria; FIB-4; Liver stiffness measurement

Outcome Measures

Primary Outcomes (1)

• Presence of High-Risk Varices Identified by Esophagogastroduodenoscopy in Patients with Compensated Chronic Hepatitis B-related Cirrhosis

  The HRV presence will be assessed during EGD, which is typically performed during the study participation period (between February 2026 and October 2026).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (aged ≥18 years) with compensated chronic hepatitis B-related cirrhosis who underwent upper gastrointestinal endoscopy and abdominal magnetic resonance imaging (MRI) including intravoxel incoherent motion (IVIM) sequences. All participants met predefined clinical, histological, or imaging-based diagnostic criteria for cirrhosis and had available endoscopic assessment for the evaluation of esophageal and/or gastric varices. Patients with decompensated cirrhosis, other chronic liver diseases, prior portosystemic shunt or splenectomy, previous variceal treatment, severe hepatic or splenic iron deposition, or malignancy were excluded.

You may qualify if:

• 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.

You may not qualify if:

• Co-existing chronic liver diseases.
• Previous portosystemic shunt treatment or splenectomy.
• A history of treatment for upper gastrointestinal varices that affects the assessment.
• Severe hepatic or splenic iron deposition.
• Decompensated cirrhosis.
• Co-existing malignancies.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice President of Beijing Friendship Hospital of Captial Medical University (Beijing)

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03