Tokyo, Dec. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060020) titled 'Reproducibility of liver stiffness measurement using EUS-SWE and its association with a simple platelet count and AST/ALT ratio-based risk stratification in steatotic liver disease: a prospective observational study' on Dec. 9.
Study Type:
Observational
Primary Sponsor:
Institute - HITO Medical Center
Condition:
Condition - steatotic liver disease (SLD)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the reproducibility (primary) and clinical validity (secondary) of liver stiffness (kPa) measured by EUS-SWE in patients with steatotic liver disease (SLD), including MASLD/MetALD/ALD. Clinical validity will be assessed by its association with a Baveno VII-referenced alternative stratification based on platelet count (PLT) and the AST/ALT ratio (AAR) (PLT-AAR).
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Inclusion criteria: (1) Adults aged 20 years and older clinically diagnosed with SLD (MASLD/MetALD/ALD) scheduled to undergo EUS as part of routine care; (2) ability to provide written informed consent.
Key exclusion criteria - Exclusion criteria: conditions judged unsuitable for EUS (e.g., severe general condition, high bleeding risk), pregnancy or suspected pregnancy, comorbidities or cognitive impairment interfering with participation, or any other reason deemed inappropriate by the principal investigator.
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 01 Day
Anticipated trial start date - 2025 Year 12 Month 09 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=R000068646
Disclaimer: Curated by HT Syndication.
