Skip to content

Endosonographic Shear Wave Elastography to Assess Liver and Splenic Fibrosis

Endosonographic Shear Wave Elastography to Assess Liver Fibrosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06867731
Acronym
EUS SWE liver
Enrollment
124
Registered
2025-03-10
Start date
2025-01-30
Completion date
2025-12-01
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver Fibrosis

Keywords

Liver Fibrosis, Elastography, Liver Biopsy, Shear Wave Elastography, Endosonographic Shear Wave Elastography

Brief 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.

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.

Interventions

PROCEDUREEndosonographic 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_TESTEndosonographic 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.

Sponsors

Providence Medical Research Center
Lead SponsorOTHER
Fujifilm
CollaboratorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Degree of fibrosisEnrollment to 4 weeksAssessment of shear wave elastography as a surrogate for histological grade of liver fibrosis

Secondary

MeasureTime frameDescription
Comparative lobar pressureEnrollment to 4 weeksCompare elastography values with standard or increased pressure
Spleen elasticityEnrollment to 4 weeksCorrelation of splenic elastography with portal pressures

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDivyanshoo R Kohli, MD FACG FASGE

Providence Sacred Heart Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026