Liver SteatosisNCT06102980
Endoscopic Ultrasound Shear Wave for Liver Fibrosis in MASLD Patients: The RUMIPAMBA Trial
A study testing Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation measurement, Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurement and Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) stiffness measurement in people with Liver Steatosis and Fibrosis, Liver, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Liver Steatosis, Fibrosis, Liver
- What is being tested?
- Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation measurement, Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurement and Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) stiffness measurement
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEcuador
- Study dates
- 1 Nov 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for any kind of endoscopic procedure.
- Without clinical suspicion of advanced liver fibrosis.
- Acceptance to participate in the study.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Ecuador1 site, 1 recruiting
- Recruiting
Instituto Ecuatoriano de Enfermedades Digestivas (IECED) Gastroclinica SA
Guayaquil, Guayas, 090505
Miguel Puga-Tejada, MD MSc, +353 87 686 0537, mpuga@ieced.ec
Jorge Baquerizo-Burgos, MD, +593 98 962 7111, jorgebaquerizoburgos@gmail.com
About this study
Official title: Estimation of Liver Fibrosis in Patients With MASLD Screening Criteria Through Endoscopic Ultrasound-guided Shear Wave vs Transabdominal Ultrasound and Transient Elastography: The RUMIPAMBA Diagnostic 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.
Read the 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 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.
- Conditions
- Liver Steatosis, Fibrosis, Liver
- Being tested
- Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation measurement, Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurement, Vibration-controlled transient elastography (VCTE) attenuation measurement, Vibration-controlled transient elastography (VCTE) stiffness measurement, Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) stiffness measurement
- Keywords
- Liver steatosis, Fatty liver, Endosonography, Elastography, Liver fibrosis
- Medical subject headings
- Fatty Liver, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation measurementDevice
Also called 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.
Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurementDevice
Also called US-SWE stiffness
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 measurementDevice
Also called 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.
Vibration-controlled transient elastography (VCTE) stiffness measurementDevice
Also called VCTE measurement
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 measurementDevice
Also called EUS-SWE attenuation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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, Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six months
Secondary outcomes (4)
Vibration-controlled transient elastography (VCTE) liver fibrosis grade
Liver steatosis will be defined by elastography using kilopascals.
Measured: Six months
Transparietal ultrasound (US)-based shear wave elastography (SWE) liver fibrosis grade
Liver steatosis will be defined by elastography using kilopascals.
Measured: 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.
Measured: 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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Nov 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Liver SteatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Robles-Medranda, Instituto Ecuatoriano de Enfermedades Digestivas
- Investigators
- Carlos Robles-Medranda, MD, Principal investigator, Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102980
- Sponsor's protocol ID
- IECED-02102023
- Status last verified
- Sep 2024
- First submitted
- 2 Oct 2023
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37482477Liu 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.
PubMed 37565905De 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.
PubMed 32405182Pandyarajan 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.
PubMed 31391806Kohli 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.
PubMed 36049537
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Liver Fibrosis in Patients With MASLD Screening Criteria Through Endoscopic Ultrasound-guided Shear Wave vs Transabdominal Ultrasound and Transient Elastography: The RUMIPAMBA Diagnostic Trial
- ClinicalTrials.gov ID
- NCT06102980
- Acronym / sponsor ID
- IECED-02102023
- Conditions
- Liver Steatosis, Fibrosis, Liver
- Keywords
- Liver steatosis, Fatty liver, Endosonography, Elastography, Liver fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades DigestivasUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MASLD screening patients | Active comparator | 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 measurementPatients 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 | Other | 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 measurementPatients 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, |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients referred for any kind of endoscopic procedure.
- Without clinical suspicion of advanced liver fibrosis.
- Acceptance to participate in the study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation measurementAlso: US-SWE attenuationThe 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. | Device | Controls, MASLD screening patients |
| Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurementAlso: US-SWE stiffnessThe 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. | Device | Controls, MASLD screening patients |
| Vibration-controlled transient elastography (VCTE) attenuation measurementAlso: VCTE attenuationThe 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. | Device | Controls, MASLD screening patients |
| Vibration-controlled transient elastography (VCTE) stiffness measurementAlso: VCTE measurementThe 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. | Device | Controls, MASLD screening patients |
| Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) stiffness measurementAlso: EUS-SWE attenuationEUS-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. | Device | Controls, MASLD screening patients |
Primary outcome
Vibration-controlled transient elastography (VCTE) liver steatosis grade
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Vibration-controlled transient elastography (VCTE) liver fibrosis grade
Time frame: Six months
Transparietal ultrasound (US)-based shear wave elastography (SWE) liver fibrosis grade
Time frame: Six months
Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) liver fibrosis grade
Time frame: Six months
Endoscopic ultrasound (EUS)-guided liver biopsy fibrosis grade
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Background: PubMed 37482477Yazdani 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.
- Background: PubMed 37565905Liu 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.
- Background: PubMed 32405182De 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.
- Background: PubMed 31391806Pandyarajan 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.
- Background: PubMed 36049537Kohli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Robles-Medranda, MD principal investigator
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation measurement, Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurement and Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) stiffness measurement in people with Liver Steatosis and Fibrosis, Liver, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miguel Puga-Tejada, MD (+353 87 686 0537, mpuga@ieced.ec), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vibration-controlled transient elastography (VCTE) liver steatosis grade (time frame: Six months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06102980, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.