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

Providence Medical Research Center

Status

Invitation-only

Conditions

Cirrhosis

Liver Fibrosis

Treatments

Diagnostic Test: Endosonographic shear wave elastography

Procedure: Endosonographic Elastography

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06867731

2024000651

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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