Endoscopic Ultrasound Shear Wave for Liver Fibrosis in MASLD Patients: The RUMIPAMBA Trial
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
Instituto Ecuatoriano de Enfermedades Digestivas
30 participants
Nov 1, 2023
INTERVENTIONAL
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
Inclusion Criteria3
- Patients referred for any kind of endoscopic procedure.
- Without clinical suspicion of advanced liver fibrosis.
- Acceptance to participate in the study.
Exclusion Criteria4
- 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.
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Interventions
The operator will be blinded to any clinical record. Before US-SWE, the patient must be fasted for a minimum of 4 hours and must remain alcohol-free for 7 days. Using an Aloka Arietta 850 (Olympus America, PA, USA), each patient must be supine. Upon breath-hold at the end of expiration, ten measurements will be obtained with the probe placed in the area of the right hepatic lobe through an intercostal space.
The operator will be blinded to any clinical record. Before US-SWE, the patient must be fasted for a minimum of 4 hours and must remain alcohol-free for 7 days. Using an Aloka Arietta 850 (Olympus America, PA, USA), each patient must be supine. Upon breath-hold at the end of expiration, ten measurements will be obtained with the probe placed in the area of the right hepatic lobe through an intercostal space.
The operator will be blinded to any clinical record. Before VCTE, the patient must be fasted for a minimum of 4 hours and must remain alcohol-free for 7 days. Using the FibroScan® Compact 530 (Echosens, Paris, France), each patient must be supine with the right arm in abduction and the ipsilateral hand resting under the head. Upon breath-hold at the end of expiration, ten measurements will be obtained with the M-probe placed in the area of the right hepatic lobe through an intercostal space. Transition to an extra large probe will be based on a VCTE automatic probe selection tool prompt.
The operator will be blinded to any clinical record. Before VCTE, the patient must be fasted for a minimum of 4 hours and must remain alcohol-free for 7 days. Using the FibroScan® Compact 530 (Echosens, Paris, France), each patient must be supine with the right arm in abduction and the ipsilateral hand resting under the head. Upon breath-hold at the end of expiration, ten measurements will be obtained with the M-probe placed in the area of the right hepatic lobe through an intercostal space. Transition to an extra large probe will be based on a VCTE automatic probe selection tool prompt.
EUS-SWE will be performed by an experienced endoscopist, blinded to clinical records. The expert will use the ArrietaTM 850 EUS console (Fujifilm, Tokyo, Japan) using a linear ultrasound video gastroscope EUS-J10 (Pentax Medical, Hoya Corp, Japan). Both lobes will be evaluated. The transducer will be positioned in the gastric window to visualize right liver segment number five and left liver segment two or three. The elastogram region of interest (ROI) will be placed within the liver tissue at a distance ≥10 mm beneath the hepatic capsule in an area free of vessels and artefacts. A 10-mm circular ROI will be placed within the elastogram at a depth of 4-5 cm from the skin, and a minimum of ten successful kilopascal measurements will be obtained. In the first stage of this research, the EUS-SWE measurement will be limited to the estimation of liver fibrosis only. Currently, available EUS-SWE equipment does not allow the estimation of the attenuation.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06102980