Actively Recruiting

Phase Not Applicable
Age: 18Years - 79Years
All Genders
ID06102980

Estimation of Liver Fibrosis in Patients With MASLD Screening Criteria Through Endoscopic Ultrasound-guided Shear Wave vs Transabdominal Ultrasound and Transient Elastography The RUMIPAMBA Diagnostic Trial

Led by Instituto Ecuatoriano de Enfermedades Digestivas · Updated on 2024-09-24

30

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Endoscopic Ultrasound Shear Wave for Liver Fibrosis in MASLD Patients: The RUMIPAMBA Trial

Who Can Participate

Age: 18Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients referred for any kind of endoscopic procedure
  • Without clinical suspicion of advanced liver fibrosis
  • Acceptance to participate in the study
Not Eligible

You will not qualify if you...

  • History of consuming more than 140 g/week (females) or 210 g/week (males) of alcohol
  • Significant or advanced fibrosis by Fibrosis-4 Index (FIB4) or aspartate aminotransferase to platelet ratio index (APRI)
  • Any liver space-occupying lesion detected by ultrasound
  • Conditions that contraindicate interventional procedures such as pregnancy, nursing, bleeding risk, severe heart failure, or high anesthesia risk

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Trial Site Locations

Total: 1 location

1

Instituto Ecuatoriano de Enfermedades Digestivas (IECED) Gastroclinica SA

Guayaquil, Guayas, Ecuador, 090505

Actively Recruiting

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Research Team

M

Miguel Puga-Tejada, MD

J

Jorge Baquerizo-Burgos, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Published Research Related To This Trial

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/37482477

Application of noninvasive test (acoustic attenuation imaging and ultrasonic shear wave elastography) to grade nonalcoholic fatty liver disease: An observational study.

Guo Tao Liu, Qing Feng Ni, Yu Hang Zhang...

https://pubmed.ncbi.nlm.nih.gov/37565905

Comparative accuracy of endosonographic shear wave elastography and transcutaneous liver stiffness measurement: a pilot study.

Divyanshoo R Kohli, Daniel Mettman, Nevene Andraws...

https://pubmed.ncbi.nlm.nih.gov/36049537