Status:
RECRUITING
Endoscopic Ultrasound Shear Wave for Liver Fibrosis in MASLD Patients: The RUMIPAMBA Trial
Lead Sponsor:
Instituto Ecuatoriano de Enfermedades Digestivas
Conditions:
Liver Steatosis
Fibrosis, Liver
Eligibility:
All Genders
18-79 years
Phase:
NA
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 met...
Detailed Description
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly non-alcoholic fatty liver disease (NAFLD), is an umbrella term which involves simple liver steatosis, metabolic-associated st...
Eligibility Criteria
Inclusion
- Patients referred for any kind of endoscopic procedure.
- Without clinical suspicion of advanced liver fibrosis.
- Acceptance to participate in the study.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06102980
Start Date
November 1 2023
End Date
April 1 2025
Last Update
September 24 2024
Active Locations (1)
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1
Instituto Ecuatoriano de Enfermedades Digestivas (IECED) Gastroclinica SA
Guayaquil, Guayas, Ecuador, 090505