Endosonographic Shear Wave Elastography for Liver Stiffness

Midwest Biomedical Research Foundation

Status: Unknown

Conditions: Liver Cirrhosis

Treatments: Diagnostic Test: Elastography

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04533932

MBRF

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Elastography

Treatment:

Diagnostic Test: Elastography