Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 5:47 PM
Study NCT ID:
NCT07450651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatic and Splenic Microcirculatory Perfusion for Ruling Out High-Risk Varices in Patients With Hepatitis B-Related Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-11-01', 'size': 299074, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-03-01T09:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-01', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of High-Risk Varices Identified by Esophagogastroduodenoscopy in Patients with Compensated Chronic Hepatitis B-related Cirrhosis', 'timeFrame': 'The HRV presence will be assessed during EGD, which is typically performed during the study participation period (between February 2026 and October 2026).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intravoxel incoherent motion', 'Hepatic microcirculation', 'Splenic microcirculation', 'High-risk varices', 'Baveno VI criteria', 'FIB-4', 'Liver stiffness measurement'], 'conditions': ['Hepatitis B Virus Related Cirrhosis', 'Portal Hypertension Related to Cirrhosis', 'Esophagogastric Varices']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'This retrospective cohort study aims to evaluate whether hepatic and splenic intravoxel incoherent motion (IVIM) diffusion-weighted MRI parameters can noninvasively identify and "rule out" high-risk esophagogastric varices (HRV) in patients with chronic hepatitis B virus (HBV)-related cirrhosis or advanced chronic liver disease. The study is based on the Beijing Friendship Hospital All-Disease Platform and will include consecutive eligible patients up to October 31, 2025. Patients who underwent both upper gastrointestinal endoscopy and abdominal MRI including IVIM sequences within a 6-month interval will be included. Endoscopic findings will serve as the reference standard, and participants will be categorized into HRV and non-HRV groups (the definition of HRV follows the registered outcome measures).\n\nImage Acquisition, Parameter Extraction, and Quality Control\n\nIVIM analysis will be performed using multi-b-value diffusion-weighted imaging data and fitted with a biexponential model to separate true molecular diffusion from microcirculatory perfusion effects. Quantitative parameters will be derived from both liver and spleen, including D (true diffusion coefficient), D\\* (pseudo-diffusion coefficient reflecting perfusion-related components), f (perfusion fraction), and ADC (apparent diffusion coefficient). To minimize the influence of focal vessels, bile ducts, and obvious artifacts on parameter fitting, parameter extraction will be conducted only after image quality assessment. Sequences with suspected artifacts or significant distortion will be excluded or flagged to ensure data reliability. Hepatic and splenic IVIM parameters will serve as key independent variables for subsequent diagnostic performance evaluation and model development.\n\nComparator Indices, Clinical Variables, and Stratified Analyses\n\nCommonly used noninvasive indices, including Baveno VI criteria, FIB-4, and APRI (calculated from routine laboratory and clinical data), will be included as comparators. Additional covariates will include demographic characteristics, complete blood count, coagulation profile, liver function tests, and liver stiffness measurement (LSM), when available. These variables will be used to describe baseline characteristics, control for potential confounding, and construct combined predictive models. In addition to the binary HRV outcome, associations between IVIM parameters and variceal severity grading as well as key clinical indicators will be explored. Prespecified subgroup analyses will be conducted to assess the diagnostic consistency and robustness of IVIM across different clinical subpopulations.\n\nStatistical Analysis, Model Development, and Evaluation of the "Rule-Out" Strategy\n\nContinuous variables will be expressed as mean ± standard deviation or median (interquartile range) after testing for normality, and categorical variables will be presented as frequencies and percentages. Between-group comparisons will be performed using the independent-samples t test or Mann-Whitney U test according to data distribution, while categorical variables will be compared using the chi-square test or Fisher\'s exact test. The diagnostic performance of individual hepatic and splenic IVIM parameters and their combinations for HRV will first be evaluated using receiver operating characteristic (ROC) curves and area under the curve (AUC). AUC values will be compared with those of noninvasive indices (Baveno VI, FIB-4, and APRI) using the DeLong test.\n\nSubsequently, a multivariable logistic regression model will be constructed to develop an IVIM-based combined prediction model. To support a clinically applicable "rule-out" strategy, model performance will be evaluated under a prespecified sensitivity threshold of ≥95%, and the proportions of potentially avoided endoscopic examinations and missed HRV cases will be calculated for different candidate models to balance clinical benefit and safety. Internal validation will be performed using bootstrap resampling (B = 1000) to obtain bias-corrected AUC estimates and assess model stability. Correlation analyses will be conducted to examine relationships between IVIM parameters and variceal grading, platelet count, LSM, FIB-4, and APRI. All statistical tests will be two-sided, and P \\< 0.05 will be considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT07450651', 'briefTitle': 'Hepatic and Splenic Microcirculatory Perfusion for Ruling Out High-Risk Varices in Patients With Hepatitis B-Related Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BFHHZS20250369'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Vice President of Beijing Friendship Hospital of Captial Medical University (Beijing)', 'investigatorFullName': 'Hong You', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}