Using endoscopic ultrasound to assess liver fibrosis in patients with metabolic dysfunction-associated steatotic liver disease
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
This study is testing if a new ultrasound technique can better check for liver damage in people with metabolic dysfunction-associated steatotic liver disease compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Instituto Ecuatoriano de Enfermedades Digestivas Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guayaquil, Guayas) |
| Trial ID | NCT06102980 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of endoscopic ultrasound-guided shear wave elastography (EUS-SWE) in assessing liver fibrosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). The study compares EUS-SWE with traditional vibration-controlled transient elastography (VCTE), which has limitations in overweight patients and in assessing certain liver regions. Participants will undergo various non-invasive elastography measurements to determine the accuracy and reliability of EUS-SWE in diagnosing liver conditions. The trial aims to provide a more reliable alternative to liver biopsy for patients with absent-to-mild fibrosis.
Who should consider this trial
Good fit: Ideal candidates for this study are patients referred for endoscopic procedures who do not have clinical suspicion of advanced liver fibrosis.
Not a fit: Patients with significant or advanced liver fibrosis or those with contraindications to interventional procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and less invasive assessments of liver fibrosis, improving patient management and outcomes.
How similar studies have performed: While similar studies have utilized VCTE, the use of EUS-SWE in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients referred for any kind of endoscopic procedure. * Without clinical suspicion of advanced liver fibrosis. * Acceptance to participate in the study. Exclusion Criteria: * History of greater amounts of alcohol per week (140 g/week and 210 g/week for females and males respectively). * Significant or advanced fibrosis by Fibrosis-4 Index (FIB4) or the aspartate aminotransferase to platelet ratio index (APRI). * Any liver space-occupying lesion in the US. * Comorbidities or conditions related to avoidance of interventional procedures, namely: pregnancy or nursing, coagulopathy or any risk of bleeding, Anaesthesiology Society Association classification IV or higher, New York Heart Association functional class III or IV.
Where this trial is running
Guayaquil, Guayas
- Instituto Ecuatoriano de Enfermedades Digestivas (IECED) Gastroclinica SA — Guayaquil, Guayas, Ecuador (Recruiting)
Study contacts
- Principal investigator: Carlos Robles-Medranda, MD — Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
- Study coordinator: Miguel Puga-Tejada, MD
- Email: mpuga@ieced.ec
- Phone: +353 87 686 0537
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.