Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062754) titled 'A Study Comparing Liver Stiffness Measured Using Endoscopic Ultrasound with Liver Biopsy Findings in Patients with Steatotic Liver Disease' on Aug. 31.

Study Type: Observational

Primary Sponsor: Institute - HITO Medical Center

Condition: Condition - Steatotic Liver Disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the association between liver stiffness measured by EUS-SWE and the degree of histological liver fibrosis assessed using liver biopsy specimens processed and diagnosed as part of routine clinical care. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients aged 20 years or older. 2. Patients with steatotic liver disease (SLD) who have been found to have hepatic steatosis on liver imaging, such as abdominal ultrasonography, computed tomography (CT), or magnetic resonance imaging (MRI). 3. Patients scheduled to undergo upper gastrointestinal endoscopic ultrasonography (EUS) as part of routine clinical care. 4. Patients considered able to undergo attempted liver stiffness measurement using EUS-SWE. 5. Patients who have received an explanation of the study objectives and procedures and are able to provide written informed consent to participate. Key exclusion criteria - 1. Patients in whom EUS is considered inappropriate. 2. Patients in whom a safe needle trajectory cannot be secured when EUS-guided liver biopsy is to be performed. 3. Patients considered to be at high risk of bleeding. 4. Patients for whom interruption or management of antithrombotic therapy is difficult and EUS-guided liver biopsy is therefore considered inappropriate. 5. Patients with a severely impaired general condition. 6. Patients who are pregnant or highly likely to be pregnant. 7. Patients with comorbidities or cognitive impairment that would interfere with participation in the study. 8. Patients otherwise deemed unsuitable for participation by the principal investigator or a study investigator. Target Size - 120

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 07 Month 26 Day Date of IRB - 2026 Year 08 Month 13 Day Anticipated trial start date - 2026 Year 08 Month 13 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071850

Disclaimer: Curated by HT Syndication.