Health Trials

Endoscopic Ultrasound Shear Wave for Liver Fibrosis in MASLD Patients: The RUMIPAMBA Trial

ConditionsLiver SteatosisFibrosis, Liver
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation measurement

    Device

    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.

  • Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurement

    Device

    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.

  • Vibration-controlled transient elastography (VCTE) attenuation measurement

    Device

    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.

  • Vibration-controlled transient elastography (VCTE) stiffness measurement

    Device

    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.

  • Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) stiffness measurement

    Device

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: MASLD screening patientsActive comparator 5 interventions
Group B: ControlsOther 5 interventions

Trial outcomes

Primary outcomes

1

Vibration-controlled transient elastography (VCTE) liver steatosis grade

Liver steatosis will be defined by elastography using the controlled attenuation parameter (CAP), measured in decibels per meter.

Time frame
Six months
2

Transparietal ultrasound (US)-based shear wave elastography (SWE) liver steatosis grade

Liver steatosis will be defined by elastography using the attenuation coefficient (ATT), measured in decibels per meter. The ATT corresponds to the VCTE CAP measurement.

Time frame
Six months
3

Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) liver steatosis grade

Liver steatosis per hepatic lobe will be defined by elastography using the attenuation coefficient (ATT) measurement. The ATT corresponds to the VCTE CAP measurement.

Time frame
Six months
4

Endoscopic ultrasound (EUS)-guided liver biopsy steatosis grade

The EUS-guided liver biopsy findings, per hepatic lobe, will be standardised through the steatosis-Activity-Fibrosis (SAF) score. The SAF scores steatosis (0-3), ballooning degeneration (0-2), lobular inflammation (0-2), and fibrosis (0-4). Liver steatosis is present when proper steatosis is present, and when both features of activity (ballooning and lobular inflammation) display at least grade 1.

Time frame
Six months

Secondary outcomes

1

Vibration-controlled transient elastography (VCTE) liver fibrosis grade

Liver steatosis will be defined by elastography using kilopascals.

Time frame
Six months
2

Transparietal ultrasound (US)-based shear wave elastography (SWE) liver fibrosis grade

Liver steatosis will be defined by elastography using kilopascals.

Time frame
Six months
3

Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) liver fibrosis grade

Liver steatosis per hepatic lobe will be defined by elastography using kilopascals.

Time frame
Six months
4

Endoscopic ultrasound (EUS)-guided liver biopsy fibrosis grade

The EUS-guided liver biopsy findings, per hepatic lobe, will be standardised through the Brunt system.

Time frame
Six months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto Ecuatoriano de Enfermedades Digestivas

Lead sponsor

Source ClinicalTrials.gov
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