An interventional study of Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation measurement and Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurement in Liver Steatosis and Fibrosis, Liver, sponsored by Instituto Ecuatoriano de Enfermedades Digestivas. Recruiting at 1 site in Ecuador. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by Instituto Ecuatoriano de Enfermedades Digestivas · Not applicable, Interventional, and Diagnostic
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.
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 the punction.
There are non-invasive resources useful for the screening and surveillance of liver steatosis and fibrosis. Apart from serum biomarkers, non-invasive technologies designed for this purpose use transabdominal 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 the anatomical proportions of the patients, and it permits a more reliable right hepatic lobe evaluation. However, it is an invasive and high-cost procedure.
VCTE, US-ARFI and EUS-SWE determine liver fibrosis quantitatively in terms of liver stiffness through kiloPascals. 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 VCTE, US-ARFI and EUS-SWE have concentrated on liver fibrosis or cirrhosis, but they have not been compared head-to-head in the context of absent-to-mild liver fibrosis vs controls. Third, there is no determined diagnostic accuracy for EUS-SWE for an early liver fibrosis estimation in MASLD patients. It is useful considering EUS is becoming a more popular procedure. Finally, and to be consequent with the third point, the identification and grading of liver steatosis and fibrosis still need to be described in the nowadays called MASLD patients.
The present study aims to determine the difference in the estimation of liver fibrosis among VCTE, US-ARFI and EUS-SWE in patients with clinical criteria of MASLD screening but absent-to-mild liver fibrosis, according to non-invasive methods.
This study has been called by the authors through the acronym RUMIPAMBA, which means "Role of endoscopic Ultrasound-guided shear wave for MASLD-related liver steatosis and fibrosis Identification in Patients with Absent to Mild Basal fibrosis, based on non-invasive Analytical laboratory tests". In the general culture, Rumipamba is the name of an archaeological prehispanic and preincaic park from Quito, the capital city of Ecuador.
662 studies on the registry are indexed under Fatty Liver; 184 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 431 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →Instituto Ecuatoriano de Enfermedades Digestivas is the lead sponsor of 39 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
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
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
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
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
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
Vibration-controlled transient elastography (VCTE) liver fibrosis grade
Liver steatosis will be defined by elastography using kilopascals.
Time frame: Six months
Transparietal ultrasound (US)-based shear wave elastography (SWE) liver fibrosis grade
Liver steatosis will be defined by elastography using kilopascals.
Time frame: Six months
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
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
Plan to share: No
Started Nov 2023 (actual). Primary completion is estimated for Dec 2024, 13 months after the start.
Of 136 non-industry interventional studies with no phase under Fatty Liver, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 13 months is below that.
Counting every sponsor, half of 145 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
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Instituto Ecuatoriano de Enfermedades Digestivas