Endosonographic Shear Wave Elastography to Assess Liver and Splenic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-30

Study Completion Date

2027-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate Liver Stiffness With Shear Wave Elastography

NCT05097963

Chronic Liver Disease Advanced Fibrosis Advanced Cirrhosis

COMPLETED NA

Liver Fibrosis Assessment With ShearWave Elastography

NCT02181452

Liver Fibrosis

COMPLETED

Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

NCT03637959

Liver Fibrosis

COMPLETED NA

ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B

NCT02313649

Liver Fibrosis

COMPLETED

Endosonographic Shear Wave Elastography for Liver Stiffness

NCT04533932

Liver Cirrhosis

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Fibrosis Cirrhosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Elastography

Diagnostic test: Endosonographic shear wave elastography

Endosonographic Elastography

Intervention Type PROCEDURE

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 elastography

Intervention Type DIAGNOSTIC_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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No