Loading clinical trials...
Loading clinical trials...
Endosonographic Shear Wave Elastography to Assess Liver Fibrosis
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Providence Sacred Heart Medical Center
Spokane, Washington, United States
Start Date
January 30, 2025
Primary Completion Date
January 30, 2026
Completion Date
January 30, 2027
Last Updated
May 30, 2025
120
ESTIMATED participants
Endosonographic Elastography
PROCEDURE
Endosonographic shear wave elastography
DIAGNOSTIC_TEST
Lead Sponsor
Providence Medical Research Center
Collaborators
NCT05597488
NCT04429100
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06632444