Liver FibrosisEUS SWE liverNCT06867731
Endosonographic Shear Wave Elastography to Assess Liver and Splenic Fibrosis
An observational study of Liver Fibrosis and Cirrhosis, run by Providence Medical Research Center at 1 site in United States.
Trial summary
The study is being done to collect information on the effectiveness of endosonographic elastography (a technique which uses sound waves) to measure the stiffness of the liver and spleen. Investigators are trying to determine if shear wave elastography is a good way to measure fibrosis instead of biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis, Cirrhosis
- What is being tested?
- Endosonographic Elastography and Endosonographic shear wave elastography
- Type of treatment
- Surgery or procedure
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2025to 1 Dec 2025
- 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 standard-of-care upper endoscopic ultrasound for liver biopsy or for other interventions in patients with known cirrhosis
Who may be able to join
- Age > 18 years (irrespective of sex)
- Patients determined clinically to have liver cirrhosis needing EUS for other reasons
- Patients determined clinically to be candidates for EUS guided liver biopsy
- Elevated liver enzymes without obvious etiology
- Clinical concern for cirrhosis requiring histological confirmation
- Patients with known cirrhosis without diagnostic dilemma
- Ability to provide informed consent and willing to participate
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
About this study
Official title: Endosonographic Shear Wave Elastography to Assess Liver Fibrosis
The study is being done to collect information on the effectiveness of endosonographic elastography (a technique which uses sound waves) to measure the stiffness of the liver and spleen. Investigators are trying to determine if shear wave elastography is a good way to measure fibrosis instead of biopsy.
Read the detailed description
Study design This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy of Endoscopic ultrasound guided shear wave elastography (EUS-SWE) with liver biopsy for liver fibrosis.
Patients who will undergo a standard-of-care EUS guided liver biopsy (or have clinically obvious liver cirrhosis) will be prospectively enrolled after obtaining informed consent. All enrolled patients will undergo EUS guided liver biopsy, unless they have an obvious diagnosis of cirrhosis. EUS-SWE of the liver and spleen.
In selected patients who have been referred for EUS PPG measurement in addition to EUS liver biopsy, portal pressures will be measured as well and correlated with elastography of the spleen.
The patients will be initially assessed for need for liver biopsy by the gastroenterology/hepatology team as per the current standard of care. Only patients with a clear clinical indication for liver biopsy will be enrolled for the study.
Per current standard of practice at Providence Sacred Heart Medical Center, patients who need liver biopsy are referred to the interventional GI service for the procedure. These patients will be offered participation in the trial prior the endoscopic procedure. This detailed discussion will include participation in the study, background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up.
- Conditions
- Liver Fibrosis, Cirrhosis
- Being tested
- Endosonographic Elastography, Endosonographic shear wave elastography
- Keywords
- Liver Fibrosis, Elastography, Liver Biopsy, Shear Wave Elastography, Endosonographic Shear Wave Elastography
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endosonographic ElastographyProcedure or surgery
The patient will undergo a standard-of-care endoscopic ultrasound with liver biopsy. At the time, elastography of the liver and spleen will be performed while using the echoendoscope. Different degrees of pressure will be applied while performing elastography of the left and right lobes of the liver as well as the spleen. The E values and VsN values will be recorded and then compared to liver histology.
Endosonographic shear wave elastographyDiagnostic test
The patient will undergo an upper endoscopic ultrasound procedure. During this procedure, the patient will be put to sleep and a trained endosonographer physician will insert an echo-endoscope through the mouth and guide it down to the stomach and the duodenum. This endoscope is equipped with technology that uses sound waves to assess the stiffness of the liver and spleen. For research purposes, the doctor will also press on these organs in order to take the additional measurements.
| Study group | Role | What they receive |
|---|---|---|
| Elastography | Diagnostic test: Endosonographic shear wave elastography Receives: Procedure: Endosonographic Elastography; Diagnostic Test: Endosonographic shear wave elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of fibrosis
Assessment of shear wave elastography as a surrogate for histological grade of liver fibrosis
Measured: Enrollment to 4 weeks
Secondary outcomes (2)
Comparative lobar pressure
Compare elastography values with standard or increased pressure
Measured: Enrollment to 4 weeks
Spleen elasticity
Correlation of splenic elastography with portal pressures
Measured: Enrollment to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start30 Jan 2025
- Primary completion31 Oct 2025
- Study completion1 Dec 2025
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 FibrosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Medical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fujifilm
- Responsible party
- Principal investigator, Divyanshoo Kohli, Providence Medical Research Center
- Investigators
- Divyanshoo R Kohli, MD FACG FASGE, Principal investigator, Providence Sacred Heart Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867731
- Sponsor's protocol ID
- 2024000651
- Acronym
- EUS SWE liver
- Status last verified
- May 2025
- First submitted
- 14 Feb 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endosonographic Shear Wave Elastography to Assess Liver Fibrosis
- ClinicalTrials.gov ID
- NCT06867731
- Acronym / sponsor ID
- EUS SWE liver / 2024000651
- Conditions
- Liver Fibrosis, Cirrhosis
- Keywords
- Liver Fibrosis, Elastography, Liver Biopsy, Shear Wave Elastography, Endosonographic Shear Wave Elastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Providence Medical Research CenterUniversity, hospital or other
- Collaborators
- Fujifilm
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 10 Mar 2025 (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.
The study is being done to collect information on the effectiveness of endosonographic elastography (a technique which uses sound waves) to measure the stiffness of the liver and spleen. Investigators are trying to determine if shear wave elastography is a good way to measure fibrosis instead of biopsy.
Detailed description
Study design This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy of Endoscopic ultrasound guided shear wave elastography (EUS-SWE) with liver biopsy for liver fibrosis.
Patients who will undergo a standard-of-care EUS guided liver biopsy (or have clinically obvious liver cirrhosis) will be prospectively enrolled after obtaining informed consent. All enrolled patients will undergo EUS guided liver biopsy, unless they have an obvious diagnosis of cirrhosis. EUS-SWE of the liver and spleen.
In selected patients who have been referred for EUS PPG measurement in addition to EUS liver biopsy, portal pressures will be measured as well and correlated with elastography of the spleen.
The patients will be initially assessed for need for liver biopsy by the gastroenterology/hepatology team as per the current standard of care. Only patients with a clear clinical indication for liver biopsy will be enrolled for the study.
Per current standard of practice at Providence Sacred Heart Medical Center, patients who need liver biopsy are referred to the interventional GI service for the procedure. These patients will be offered participation in the trial prior the endoscopic procedure. This detailed discussion will include participation in the study, background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elastography | – | Procedure: Endosonographic Elastography, Diagnostic Test: Endosonographic shear wave elastographyDiagnostic test: Endosonographic shear wave elastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing standard-of-care upper endoscopic ultrasound for liver biopsy or for other interventions in patients with known cirrhosis
Key inclusion criteria (7 listed)
- Age > 18 years (irrespective of sex)
- Patients determined clinically to have liver cirrhosis needing EUS for other reasons
- Patients determined clinically to be candidates for EUS guided liver biopsy
- Elevated liver enzymes without obvious etiology
- Clinical concern for cirrhosis requiring histological confirmation
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| Endosonographic ElastographyThe patient will undergo a standard-of-care endoscopic ultrasound with liver biopsy. At the time, elastography of the liver and spleen will be performed while using the echoendoscope. Different degrees of pressure will be applied while performing elastography of the left and right lobes of the liver as well as the spleen. The E values and VsN values will be recorded and then compared to liver histology. | Procedure or surgery | Elastography |
| Endosonographic shear wave elastographyThe patient will undergo an upper endoscopic ultrasound procedure. During this procedure, the patient will be put to sleep and a trained endosonographer physician will insert an echo-endoscope through the mouth and guide it down to the stomach and the duodenum. This endoscope is equipped with technology that uses sound waves to assess the stiffness of the liver and spleen. For research purposes, the doctor will also press on these organs in order to take the additional measurements. | Diagnostic test | Elastography |
Primary outcome
Degree of fibrosis
Time frame: Enrollment to 4 weeks
Assessment of shear wave elastography as a surrogate for histological grade of liver fibrosis
2 secondary outcomes
Comparative lobar pressure
Time frame: Enrollment to 4 weeks
Spleen elasticity
Time frame: Enrollment to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: 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.
- Individual participant dataSharing planned: No
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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.
Divyanshoo R Kohli, MD FACG FASGE principal investigator
Providence Sacred Heart Medical Center
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 Fibrosis and Cirrhosis, run by Providence Medical Research Center 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 17 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of fibrosis (time frame: Enrollment to 4 weeks). 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 NCT06867731, 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 17 Sep 2026.