Endoscopic Ultrasound Shear Wave for Liver Fibrosis in MASLD Patients: The RUMIPAMBA Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorInstituto Ecuatoriano de Enfermedades Digestivas
About this trial
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.
Eligibility criteria
Qualifiers
Patients referred for any kind of endoscopic procedure.
Without clinical suspicion of advanced liver fibrosis.
Acceptance to participate in the study.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation measurement
- Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurement
- Vibration-controlled transient elastography (VCTE) attenuation measurement
- Vibration-controlled transient elastography (VCTE) stiffness measurement
- Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) stiffness measurement
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov