Endoscopic Ultrasound Shear Wave vs Transient Elastography for Liver Steatosis: The RUMIPAMBA Trial
- Conditions
- Liver SteatosisFibrosis, Liver
- Interventions
- Device: Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation measurementDevice: Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurementDevice: Vibration-controlled transient elastography (VCTE) attenuation measurementDevice: Vibration-controlled transient elastography (VCTE) stiffness measurementDevice: Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) stiffness measurement
- Registration Number
- NCT06102980
- Lead Sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Patients referred for any kind of endoscopic procedure.
- Without clinical suspicion of advanced liver fibrosis.
- Acceptance to participate in the study.
- History of greater amounts of alcohol per week (140 g/week and 210 g/week for females and males respectively).
- Significant or advanced fibrosis in accordance with FIB4 or APRI scores.
- 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, ASA IV or higher, NYHA III or IV.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MASLD screening patients Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation measurement 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. MASLD screening patients Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurement 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. MASLD screening patients Vibration-controlled transient elastography (VCTE) attenuation measurement 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. MASLD screening patients Vibration-controlled transient elastography (VCTE) stiffness measurement 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. MASLD screening patients Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) stiffness measurement 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. Controls Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation 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, Controls Transparietal ultrasound (US)-based 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, Controls Vibration-controlled transient elastography (VCTE) attenuation 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, Controls Vibration-controlled transient elastography (VCTE) 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, Controls 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,
- Primary Outcome Measures
Name Time Method Vibration-controlled transient elastography (VCTE) liver steatosis grade Six months Liver steatosis will be defined by elastography using the controlled attenuation parameter (CAP), measured in decibels per meter.
Transparietal ultrasound (US)-based shear wave elastography (SWE) liver steatosis grade Six months 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.
Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) liver steatosis grade Six months Liver steatosis per hepatic lobe will be defined by elastography using the attenuation coefficient (ATT) measurement. The ATT corresponds to the VCTE CAP measurement.
Endoscopic ultrasound (EUS)-guided liver biopsy steatosis grade Six months 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.
- Secondary Outcome Measures
Name Time Method Vibration-controlled transient elastography (VCTE) liver fibrosis grade Six months Liver steatosis will be defined by elastography using kilopascals.
Transparietal ultrasound (US)-based shear wave elastography (SWE) liver fibrosis grade Six months Liver steatosis will be defined by elastography using kilopascals.
Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) liver fibrosis grade Six months Liver steatosis per hepatic lobe will be defined by elastography using kilopascals.
Endoscopic ultrasound (EUS)-guided liver biopsy fibrosis grade Six months The EUS-guided liver biopsy findings, per hepatic lobe, will be standardised through the Brunt system.
Trial Locations
- Locations (1)
Instituto Ecuatoriano de Enfermedades Digestivas (IECED) Gastroclinica SA
🇪🇨Guayaquil, Guayas, Ecuador