Liver Cirrhosis
Conditions
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.
Interventions
DIAGNOSTIC_TESTElastography
Endosonographic shear wave elastography
Sponsors
Olympus Corporation of the Americas
Midwest Biomedical Research Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of fibrosis | through study completion, an average of 1 year | Degree of fibrosis based on histological assessment |
Countries
United States
Contacts
Primary ContactDivyanshoo R Kohli, MD
Outcome results
None listed