Endosonographic Shear Wave Elastography for Liver Stiffness
- Conditions
- Liver Cirrhosis
- Interventions
- Diagnostic Test: Elastography
- Registration Number
- NCT04533932
- Lead Sponsor
- Midwest Biomedical Research Foundation
- Brief Summary
This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy and safety of endosonographic real-time Elastography and shear wave Elastography with the current standards of care, i.e. liver biopsy and Vibration-controlled transient elastography (Fibroscan). Subjects who are referred for an endoscopic ultrasound (EUS) guided liver biopsy will be prospectively enrolled to undergo liver biopsy, Elastography and/or Vibration-controlled transient elastography.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Patients referred for EUS guided liver biopsy
- Elevated liver enzymes without obvious etiology, thus necessitating liver biopsy or clinical concern for cirrhosis or NASH requiring histological confirmation
- Ability to provide informed consent and willing to participate
Exclusion Criteria
- Clinical evidence of cirrhosis which obviates need for liver biopsy
- Noninvasive lab testing which confirms presence of cirrhosis
- Surgically altered foregut anatomy which precludes safe endoscopic liver biopsy
- Coagulopathy with INR greater than 1.6 in patients on anticoagulant therapy
- Thrombocytopenia with platelet count less than 50,000/mL
- Pregnancy (positive urine pregnancy test in females of childbearing age)
- Lack of consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Elastography Elastography -
- Primary Outcome Measures
Name Time Method Degree of fibrosis through study completion, an average of 1 year Degree of fibrosis based on histological assessment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kansas City VA Medical Center
🇺🇸Kansas City, Missouri, United States