Endosonographic Real-time and Shear Wave Elastography to Assess Liver stiffness-a Pilot Study
| Registry | NCT04533932 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 40 (Estimated) |
| Sponsor | Midwest Biomedical Research (Other); collaborators: Olympus Corporation of the Americas |
| Conditions | Liver Cirrhosis |
| Interventions | Elastography (Diagnostic test) |
| Dates | start 2020-09-08, primary completion 2021-08-01 (estimated), completion 2021-08-01 (estimated), first posted 2020-09-01, last updated 2021-02-23 |
| Locations | 1 site in United States |
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All trials for Liver Cirrhosis All trials of Elastography
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Elastography | Diagnostic Test: Elastography |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Kansas City VA Medical Center | Kansas City, Missouri | United States | Recruiting |