Ultrasound Shear Wave Attenuation Imaging for Grading Liver Steatosis in Volunteers and Patients With Non-alcoholic Fatty Liver Disease: A Pilot Study.
Ladan Yazdani, Iman Rafati, Marc Gesnik...
https://pubmed.ncbi.nlm.nih.gov/37482477Actively Recruiting
Led by Instituto Ecuatoriano de Enfermedades Digestivas · Updated on 2024-09-24
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
This research investigates the role of endoscopic ultrasound-guided shear wave elastography (EUS-SWE) in assessing liver fibrosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) who have absent-to-mild liver fibrosis. MASLD includes a range of liver conditions from simple fat accumulation to inflammation and cirrhosis. Existing methods like vibration-controlled transient elastography (VCTE) are commonly used due to lower cost and less invasiveness but have limitations in evaluating certain liver areas, especially in overweight patients. The study compares three non-invasive techniques: VCTE, transparietal ultrasound-based shear wave elastography (US-SWE), and EUS-SWE. EUS-SWE allows a more reliable evaluation of the right hepatic lobe independently of patient body anatomy but is more invasive and costly. Participants will undergo these imaging procedures to measure liver steatosis and fibrosis grades. The trial includes two groups: patients meeting MASLD screening criteria and controls without these criteria. Participants will be assessed over six months using these imaging methods to measure liver stiffness and steatosis grades. Procedures will include fasting and avoiding alcohol before imaging. EUS-SWE involves an endoscopic procedure to obtain measurements from both liver lobes. The main outcomes are liver steatosis and fibrosis grades determined by each method. Safety and accuracy of each technique will be monitored throughout the study duration.
CONDITIONS
Endoscopic Ultrasound Shear Wave for Liver Fibrosis in MASLD Patients: The RUMIPAMBA Trial
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo multiple non-invasive imaging procedures to estimate liver fibrosis and steatosis, including transabdominal ultrasound-based shear wave elastography (US-SWE), vibration-controlled transient elastography (VCTE), and endoscopic ultrasound-guided shear wave elastography (EUS-SWE).
1 to 2 visits depending on procedure scheduling
Total: 1 location
1
Instituto Ecuatoriano de Enfermedades Digestivas (IECED) Gastroclinica SA
Guayaquil, Guayas, Ecuador, 090505
Actively Recruiting
M
Miguel Puga-Tejada, MD
J
Jorge Baquerizo-Burgos, MD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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