Endoscopic Ultrasound Shear Wave for Liver Fibrosis in MASLD Patients: The RUMIPAMBA Trial
Recruiting now · Not applicable
Conditions studied: Liver Steatosis, Fibrosis, Liver
In brief
Currently, there is no description of the contribution of the endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) when describing liver fibrosis in patients with screening criteria of metabolic dysfunction-associated steatotic liver disease (MASLD), with absent-to-mild liver fibrosis. Similar research has been published but using vibration-controlled transient elastography (VCTE), recommended mainly due to its lower cost and less invasiveness. However, VCTE is limited to the anatomical proportions of the patient's body, and cannot assess the right hepatic lobe with less reliability, contrary to the EUS-SWE.
Key facts
- Study ID
- NCT06102980
- Run by
- Instituto Ecuatoriano de Enfermedades Digestivas
- People needed
- 30
- Starts
- 2023-11-01
- Expected to finish
- 2025-04-01
- Last updated by the study team
- 2024-09-24
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients referred for any kind of endoscopic procedure.
- Without clinical suspicion of advanced liver fibrosis.
- Acceptance to participate in the study.
You may not qualify if…
- 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 it is running
- Instituto Ecuatoriano de Enfermedades Digestivas (IECED) Gastroclinica SA — Guayaquil, Guayas, Ecuador (enrolling)
Full record on ClinicalTrials.gov
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