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NCT04533932 Clinical Trial

Endosonographic Shear Wave Elastography for Liver Stiffness

Liver Cirrhosis Clinical Trial

Official title:
Endosonographic Real-time and Shear Wave Elastography to Assess Liver stiffness-a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04533932
Other study ID # MBRF
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 8, 2020
Est. completion date August 2021

Study information
Verified date February 2021
Source Midwest Veterans' Biomedical Research Foundation
Contact Divyanshoo R Kohli, MD
Phone 8168614700
Email divyanshoo.kohli2@va.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date August 2021
Est. primary completion date August 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Elastography
Endosonographic shear wave elastography

Locations
Country Name City State
United States Kansas City VA Medical Center Kansas City Missouri

Sponsors (2)
Lead Sponsor Collaborator
Midwest Biomedical Research Foundation Olympus Corporation of the Americas

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Degree of fibrosis Degree of fibrosis based on histological assessment through study completion, an average of 1 year
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