NCT06102980 Endoscopic Ultrasound Shear Wave for Liver Fibrosis in MASLD Patients: The RUMIPAMBA Trial
| NCT ID | NCT06102980 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Ecuatoriano de Enfermedades Digestivas |
| Condition | Liver Steatosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-11-01 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Carlos Robles-Medranda, MD
PRINCIPAL INVESTIGATOR
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
Frequently Asked Questions
Who can join the NCT06102980 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Liver Steatosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06102980 currently recruiting?
Yes, NCT06102980 is actively recruiting participants. Contact the research team at mpuga@ieced.ec for enrollment information.
Where is the NCT06102980 trial being conducted?
This trial is being conducted at Guayaquil, Ecuador.
Who is sponsoring the NCT06102980 clinical trial?
NCT06102980 is sponsored by Instituto Ecuatoriano de Enfermedades Digestivas. The principal investigator is Carlos Robles-Medranda, MD at Instituto Ecuatoriano de Enfermedades Digestivas (IECED). The trial plans to enroll 30 participants.