Endosonographic Shear Wave Elastography to Assess Liver and Splenic Fibrosis (EUS SWE liver)

May 25, 2025 updated by: Divyanshoo Kohli, Providence Medical Research Center

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Spokane, Washington, United States, 99204
        • Providence Sacred Heart Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing standard-of-care upper endoscopic ultrasound for liver biopsy or for other interventions in patients with known cirrhosis

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elastography
Diagnostic test: Endosonographic shear wave elastography
Procedure: Endosonographic Elastography
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.
Diagnostic test: Endosonographic shear wave elastography
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of fibrosis
Time Frame: Enrollment to 4 weeks
Assessment of shear wave elastography as a surrogate for histological grade of liver fibrosis
Enrollment to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative lobar pressure
Time Frame: Enrollment to 4 weeks
Compare elastography values with standard or increased pressure
Enrollment to 4 weeks
Spleen elasticity
Time Frame: Enrollment to 4 weeks
Correlation of splenic elastography with portal pressures
Enrollment to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Providence Medical Research Center

Collaborators

Fujifilm

Investigators

  • Principal Investigator: Divyanshoo R Kohli, MD FACG FASGE, Providence Sacred Heart Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2025

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 25, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024000651

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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