Endosonographic Shear Wave Elastography for Liver Stiffness
Endosonographic Real-time and Shear Wave Elastography to Assess Liver stiffness-a Pilot Study
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2020
CompletedFirst Posted
Study publicly available on registry
September 1, 2020
CompletedStudy Start
First participant enrolled
September 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedFebruary 23, 2021
February 1, 2021
11 months
August 23, 2020
February 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Degree of fibrosis
Degree of fibrosis based on histological assessment
through study completion, an average of 1 year
Study Arms (1)
Elastography
Interventions
Eligibility Criteria
Patients undergoing liver biopsy
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Related Publications (1)
Kohli DR, Mettman D, Andraws N, Haer E, Porter J, Ulusurac O, Ullery S, Desai M, Siddiqui MS, Sharma P. Comparative accuracy of endosonographic shear wave elastography and transcutaneous liver stiffness measurement: a pilot study. Gastrointest Endosc. 2023 Jan;97(1):35-41.e1. doi: 10.1016/j.gie.2022.08.035. Epub 2022 Aug 29.
PMID: 36049537DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Endoscopy
Study Record Dates
First Submitted
August 23, 2020
First Posted
September 1, 2020
Study Start
September 8, 2020
Primary Completion
August 1, 2021
Study Completion
August 1, 2021
Last Updated
February 23, 2021
Record last verified: 2021-02