Endoscopic Ultrasound Shear Wave vs Transient Elastography for Liver Steatosis: The RUMIPAMBA Trial

Liver Steatosis Clinical Trial

Official title: Liver Steatosis Through Endoscopic Ultrasound-guided Shear Wave Elastography vs Vibration-controlled Transient Elastography: a Blinded Diagnostic Trial in Noninvasive Methods-determined Absent-to-mild Liver Fibrosis: The RUMIPAMBA Trial

Status Not yet recruiting

Clinical Trial Summary

Currently, there is no description of the contribution of the endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) when describing liver steatosis in patients with suspicion of metabolic dysfunction-associated steatotic liver disease (MASLD). Similar research have 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, in opposition to the EUS-SWE.

Clinical Trial 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 steatohepatitis (MASH) and MASH-related liver cirrhosis. Liver steatosis relies on imaging or biomarkers, but liver biopsy remains the gold standard for its diagnosis and grading. It comprehends intracellular accumulation of triacylglycerol (TAG) as microvascular or macrovascular lipid droplets in at least 5% of hepatocytes. Liver biopsy is invasive, requires a high-quality biopsy sample, can mislead a diagnosis due to sampling bias, depends on pathologist interpretation variability and implies adverse events related to punction.

There are non-invasive resources useful for liver steatosis screening and surveillance. Apart from serum biomarkers, non-invasive technologies designed for this purpose use ultrasound (US)-based elastography, namely: US strain, acoustic radiation force impulse (ARFI), point shear wave elastography (pSWE), two-dimension shear wave elastography (2D-SWE) and vibration-controlled transient elastography (VCTE). Although VCTE presents anatomical limitations when used in overweight patients or assessing the right hepatic lobe, it is largely accepted by international guidelines for assessing liver steatosis and fibrosis. Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) is independent of patients' anatomical proportions, and it permits a more reliable right hepatic lobe evaluation. However, it is an invasive and high-cost procedure.

VCTE and EUS-SWE determine liver steatosis quantitatively through the controlled attenuation parameter (CAP) and the attenuation coefficient (ATT), respectively. The ATT is equivalent to the CAP, both expressed in decibels per meter [dB/m]. There are four important gaps in the literature. First, the diagnostic accuracy of VCTE for liver steatosis has been profoundly analysed in NAFLD, but in a wide spectrum of liver fibrosis patients, from absent to cirrhosis. These limits finding extrapolations for screening and surveillance. Second, comparisons between EUS-SWE vs. VCTE have concentrated on liver fibrosis or cirrhosis. Third, there is no determined diagnostic accuracy for liver steatosis through EUS-SWE, each day more requested procedures are. Finally, as a new proposed term, liver steatosis identification and grading still need to be described in the nowadays called MASLD patients. The present study aims to compare MASLD-related liver steatosis estimation using CAP of the VCTE and the ATT of the EUS-SWE, comparing controls vs. liver steatosis patients with absent or mild liver fibrosis determined through non-invasive methods. ;

Related Conditions & MeSH terms

• Fatty Liver
• Liver Steatosis

• NCT number: NCT06102980
• Study type: Interventional
• Source: Instituto Ecuatoriano de Enfermedades Digestivas
• Contact: Miguel Puga-Tejada, MD MSc
• Phone: +5491165003311
• Email: miguel.puga01@hotmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Completion date: April 1, 2024