Chronic Liver Disease Clinical Trial
Official title:
A Prospective Study of Endoscopic Ultrasound Shear Wave Elastography for Assessment of Liver Fibrosis
The purpose of the study is to assess the diagnostic accuracy of Endoscopic Ultrasound (EUS) shear wave elastography in liver fibrosis staging in both normal subjects and subjects with advanced liver fibrosis/cirrhosis
This is a prospective, paired study. Study subjects who are scheduled to undergo EUS at Mayo Clinic will be identified through Epic. Chart review will be performed including review of prior imaging, medical history, and laboratory results as available in Epic to determine study eligibility. Subjects without history of chronic liver disease (screened by low FIB-4 score) and those with known advanced fibrosis/cirrhosis will be eligible for the study. Eligible study subjects will then be contacted either before, or at the time of their endoscopy procedure to discuss study participation. All subjects will then receive standard clinical care based on the indication for the EUS procedure. During the EUS procedure, study subjects with undergo shear wave measurements obtained in a non-invasive manner as part of the endosonographic evaluation of the liver. 10 measurements (including shear wave velocity (Vs), elastic modulus (E)) will be obtained for point SWE (pSWE). Measurements will be obtained from both left and right lobes of liver unless technically infeasible to do so. Study subjects will then undergo a paired MR elastography (same day or at later date) after completion of EUS and only if consistent and reliable shear wave measurements were obtained (e.g., VsN > 70%(reliability index of each measurement expressed in percentages), IQR/M (interquartile range/ Median) is <15% for Vs and <30% for E). Enrolled study subjects who had undergone a previous MRE (within 6 months of enrollment) would be eligible for the study, without the need to undergo further research MRE. After completion of MR elastography, the subjects will then continue through their routine clinical care and will not be followed up by research staff. The expected duration of subject participation is anticipated to begin at the time of study enrollment and terminate after completion of MR elastography. There will be no additional follow up. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03704792 -
Validation of the Second Generation of the Controlled Attenuation Parameter (CAP) Using the MRI-PDFF as Reference
|
N/A | |
Terminated |
NCT02949375 -
Trial to Examine the Effect of Two Doses of GRI-0621 in Patients With Chronic Liver Disease
|
Phase 2 | |
Active, not recruiting |
NCT01205074 -
¹³C-Methacetin Breath Test (MBT) Methodology Study
|
Phase 2/Phase 3 | |
Completed |
NCT00756171 -
Colesevelam Versus Placebo in Cholestatic Pruritus
|
Phase 2/Phase 3 | |
Completed |
NCT01195181 -
Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice.
|
Phase 4 | |
Completed |
NCT05044663 -
Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in NASH Related Compensated Advanced Chronic Liver Disease.
|
||
Recruiting |
NCT04588077 -
Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis
|
Phase 4 | |
Recruiting |
NCT04802954 -
Risk Stratification of Hepatocarcinogenesis Using a Deep Learning Based Clinical, Biological and Ultrasound Model in High-risk Patients
|
N/A | |
Recruiting |
NCT04622449 -
Etiopathogenesis of Anemia in Chronic Liver Disease
|
||
Enrolling by invitation |
NCT05836246 -
The Development of Quantitative Ultrasound Imaging Software Platform
|
||
Completed |
NCT03087344 -
Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis
|
N/A | |
Completed |
NCT04751045 -
Comparison and Outcomes of Endoscopic Ultrasound Liver Biopsies Versus Percutaneous Liver Biopsies
|
N/A | |
Not yet recruiting |
NCT04526548 -
A Diagnostic Study on Patients With Drug-induced Liver Injury
|
||
Withdrawn |
NCT02899325 -
FDGal PET/CT to Detect Hepatocellular Carcinoma
|
||
Terminated |
NCT02530567 -
Non-invasive Evaluation of Portal Pressure by MRI
|
N/A | |
Suspended |
NCT02650011 -
Clinical Features and Natural History of Acute-on-Chronic Liver Failure in Korean Patients With Chronic Liver Disease
|
||
Completed |
NCT01851252 -
MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy
|
Phase 1 | |
Terminated |
NCT01756690 -
Predicting Lung Injury From Transfusion in Patients With Liver Disease
|
N/A | |
Completed |
NCT01600105 -
Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI)
|
Phase 4 | |
Completed |
NCT01008293 -
Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life
|
Phase 2/Phase 3 |