Endosonographic Shear Wave Elastography for Liver Stiffness

Status unconfirmed

Conditions studied: Liver Cirrhosis

In brief

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.

Key facts

Study ID

NCT04533932

Run by

Midwest Biomedical Research

People needed

40

Starts

2020-09-08

Expected to finish

2021-08-01

Last updated by the study team

2021-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kansas City VA Medical Center — Kansas City, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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