Liver CirrhosisNCT04533932
Endosonographic Shear Wave Elastography for Liver Stiffness
An observational study of Liver Cirrhosis, run by Midwest Biomedical Research at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Elastography
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing liver biopsy
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Divyanshoo Kohli, MD
About this study
Official title: Endosonographic Real-time and Shear Wave Elastography to Assess Liver stiffness-a Pilot Study
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.
- Conditions
- Liver Cirrhosis
- Being tested
- Elastography
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElastographyDiagnostic test
Endosonographic shear wave elastography
| Study group | Role | What they receive |
|---|---|---|
| Elastography | Not described Receives: Diagnostic Test: Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of fibrosis
Degree of fibrosis based on histological assessment
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start8 Sep 2020
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwest Biomedical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus Corporation of the Americas
- Responsible party
- Principal investigator, Divyanshoo Kohli, MD, Kansas City Veteran Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533932
- Sponsor's protocol ID
- MBRF
- Status last verified
- Feb 2021
- First submitted
- 23 Aug 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36049537
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endosonographic Real-time and Shear Wave Elastography to Assess Liver stiffness-a Pilot Study
- ClinicalTrials.gov ID
- NCT04533932
- Acronym / sponsor ID
- MBRF
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Midwest Biomedical ResearchUniversity, hospital or other
- Collaborators
- Olympus Corporation of the Americas
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elastography | – | Diagnostic Test: Elastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing liver biopsy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElastographyEndosonographic shear wave elastography | Diagnostic test | Elastography |
Primary outcome
Degree of fibrosis
Time frame: through study completion, an average of 1 year
Degree of fibrosis based on histological assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Derived from this study: PubMed 36049537Kohli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Midwest Biomedical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Divyanshoo R Kohli, MD (8168614700, divyanshoo.kohli2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of fibrosis (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04533932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.