NCT06867731

Endosonographic Shear Wave Elastography to Assess Liver and Splenic Fibrosis

Endosonographic Shear Wave Elastography to Assess Liver Fibrosis

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Providence Medical Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Fibrosis
• Cirrhosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-30
• Primary completion: 2026-01-30
• Completion: 2027-01-30
• First posted: 2025-03-10
• Last updated: 2025-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study