Endosonographic Shear Wave Elastography to Assess Liver and Splenic Fibrosis

• Conditions: Liver Fibrosis; Cirrhosis

• Registration Number: NCT06867731
• Lead Sponsor: Providence Medical Research Center

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.

Study Timeline

• Study Start: 2025-01-30
• Study First Submitted: 2025-02-14
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2026-01-30
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of fibrosis	Enrollment to 4 weeks	Assessment of shear wave elastography as a surrogate for histological grade of liver fibrosis

Secondary Outcome Measures

Name	Time	Method
Comparative lobar pressure	Enrollment to 4 weeks	Compare elastography values with standard or increased pressure
Spleen elasticity	Enrollment to 4 weeks	Correlation of splenic elastography with portal pressures

Trial Locations

Locations (1)

Providence Sacred Heart Medical Center; 🇺🇸 Spokane, Washington, United States