Endosonographic Shear Wave Elastography for Liver Stiffness

• Conditions: Liver Cirrhosis

• 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

Study Timeline

• Study First Submitted: 2020-08-23
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-09-01
• Study Start: 2020-09-08
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-23
• Primary Completion: 2021-08
• Study Completion: 2021-08

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

Primary Outcome Measures

Name	Time	Method
Degree of fibrosis	through study completion, an average of 1 year	Degree of fibrosis based on histological assessment

Trial Locations

Locations (1)

Kansas City VA Medical Center; 🇺🇸 Kansas City, Missouri, United States