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

NCT06102980 | Recruiting

• 1 other identifier: IECED-02102023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Steatosis; Fibrosis, Liver

Keywords

Liver steatosis; Fatty liver; Endosonography; Elastography; Liver fibrosis

Outcome Measures

Primary Outcomes (4)

• 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.

  Six months

• 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.

  Six months

• 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.

  Six months

• 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.

  Six months

Secondary Outcomes (4)

• Vibration-controlled transient elastography (VCTE) liver fibrosis grade

  Six months

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

  Six months

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

  Six months

• Endoscopic ultrasound (EUS)-guided liver biopsy fibrosis grade

  Six months

Study Arms (2)

MASLD screening patients

ACTIVE COMPARATOR

Patients with requirements of screening following the European Association for the Study of the Liver (EASL) 2016 recommendations. The MASLD screening group will be compounded by patients with at least one of the following criteria: 1. Over fifty years old; 2. Body mass index (BMI) over 25 kg/m2; 3. Diabetes mellitus type 2; 4. Metabolic syndrome; or 5. Persistently elevated liver enzymes.

Device: Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation measurement; Device: Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurement; Device: Vibration-controlled transient elastography (VCTE) attenuation measurement; Device: Vibration-controlled transient elastography (VCTE) stiffness measurement; Device: Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) stiffness measurement

Controls

OTHER

Patients without requirements of screening following the European Association for the Study of the Liver (EASL) 2016 recommendations. The control group will be compounded by patients who will not present any of the following criteria: 1. Over fifty years old; 2. Body mass index (BMI) over 25 kg/m2; 3. Diabetes mellitus type 2; 4. Metabolic syndrome; and 5. Persistently elevated liver enzymes. To be a control participant does not mean that the patient is a healthy participant. The control participants are patients who request any type of endoscopy and fulfil the criteria not to screen for liver steatosis. For example, a 48-year-old male with 21 kg/m2 BMI, without diabetes mellitus type 2, any metabolic syndrome-related comorbidities, with normal liver enzymes and who refused an episode of persistently elevated liver enzymes, with persistent reflux disease after two months of proton pump inhibitor therapy,

Device: Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation measurement; Device: Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurement; Device: Vibration-controlled transient elastography (VCTE) attenuation measurement; Device: Vibration-controlled transient elastography (VCTE) stiffness measurement; Device: Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) stiffness measurement

Interventions

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.

Also known as: US-SWE attenuation

Controls; MASLD screening patients

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.

Also known as: US-SWE stiffness

Controls; MASLD screening patients

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.

Also known as: VCTE attenuation

Controls; MASLD screening patients

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.

Also known as: VCTE measurement

Controls; MASLD screening patients

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.

Also known as: EUS-SWE attenuation

Controls; MASLD screening patients

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for any kind of endoscopic procedure.
• Without clinical suspicion of advanced liver fibrosis.
• Acceptance to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Instituto Ecuatoriano de Enfermedades Digestivas (IECED) Gastroclinica SA

Guayaquil, Guayas, 090505, Ecuador

RECRUITING

Related Publications (5)

• Yazdani L, Rafati I, Gesnik M, Nicolet F, Chayer B, Gilbert G, Volniansky A, Olivie D, Giard JM, Sebastiani G, Nguyen BN, Tang A, Cloutier G. Ultrasound Shear Wave Attenuation Imaging for Grading Liver Steatosis in Volunteers and Patients With Non-alcoholic Fatty Liver Disease: A Pilot Study. Ultrasound Med Biol. 2023 Oct;49(10):2264-2272. doi: 10.1016/j.ultrasmedbio.2023.06.020. Epub 2023 Jul 21.

  PMID: 37482477 BACKGROUND

• Liu GT, Ni QF, Zhang YH, Dong XM, Zhou C, Shen B, Zhu JY, Chen YJ, Zhu Z. Application of noninvasive test (acoustic attenuation imaging and ultrasonic shear wave elastography) to grade nonalcoholic fatty liver disease: An observational study. Medicine (Baltimore). 2023 Aug 11;102(32):e34550. doi: 10.1097/MD.0000000000034550.

  PMID: 37565905 BACKGROUND

• De A, Duseja A. Natural History of Simple Steatosis or Nonalcoholic Fatty Liver. J Clin Exp Hepatol. 2020 May-Jun;10(3):255-262. doi: 10.1016/j.jceh.2019.09.005. Epub 2019 Sep 20.

  PMID: 32405182 BACKGROUND

• Pandyarajan V, Gish RG, Alkhouri N, Noureddin M. Screening for Nonalcoholic Fatty Liver Disease in the Primary Care Clinic. Gastroenterol Hepatol (N Y). 2019 Jul;15(7):357-365.

  PMID: 31391806 BACKGROUND

• Kohli DR, Mettman D, Andraws N, Haer E, Porter J, Ulusurac O, Ullery S, Desai M, Siddiqui MS, Sharma P. Comparative accuracy of endosonographic shear wave elastography and transcutaneous liver stiffness measurement: a pilot study. Gastrointest Endosc. 2023 Jan;97(1):35-41.e1. doi: 10.1016/j.gie.2022.08.035. Epub 2022 Aug 29.

  PMID: 36049537 BACKGROUND

MeSH Terms

Conditions

Fatty Liver; Liver Cirrhosis

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Carlos Robles-Medranda, MD

  Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Puga-Tejada, MD

CONTACT

+353 87 686 0537; mpuga@ieced.ec

Jorge Baquerizo-Burgos, MD

CONTACT

+593 98 962 7111; jorgebaquerizoburgos@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After EUS-SWE, a clinical research coordinator will open the label to confirm the patient's cohort. The patient will undergo the EUS-guided two-lobe liver biopsy only if the patient belongs to the liver steatosis group.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Endoscopy Division

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 26, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)