[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523997":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":52,"centralContacts":57,"locations":68,"responsibleParty":92,"collaborators":62,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":62,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":62,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":71,"whyStopped":62,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Instituto Ecuatoriano de Enfermedades Digestivas","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"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:\n\n1. Over fifty years old;\n2. Body mass index (BMI) over 25 kg\u002Fm2;\n3. Diabetes mellitus type 2;\n4. Metabolic syndrome; or\n5. Persistently elevated liver enzymes.",[13,14,15,16,17],"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",{"label":19,"type":6,"description":20,"interventionNames":21},"Controls","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:\n\n1. Over fifty years old;\n2. Body mass index (BMI) over 25 kg\u002Fm2;\n3. Diabetes mellitus type 2;\n4. Metabolic syndrome; and\n5. Persistently elevated liver enzymes.\n\nTo 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\u002Fm2 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,",[13,14,15,16,17],[23,30,35,41,46],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Transparietal ultrasound (US)-based shear wave elastography (SWE) attenuation 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.",[19,9],[29],"US-SWE attenuation",{"type":24,"name":31,"description":26,"armGroupLabels":32,"otherNames":33},"Transparietal ultrasound (US)-based shear wave elastography (SWE) stiffness measurement",[19,9],[34],"US-SWE stiffness",{"type":24,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Vibration-controlled transient elastography (VCTE) attenuation 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.",[19,9],[40],"VCTE attenuation",{"type":24,"name":42,"description":37,"armGroupLabels":43,"otherNames":44},"Vibration-controlled transient elastography (VCTE) stiffness measurement",[19,9],[45],"VCTE measurement",{"type":24,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) stiffness 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.\n\nIn 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.",[19,9],[51],"EUS-SWE attenuation",[53],{"name":54,"affiliation":55,"role":56},"Carlos Robles-Medranda, MD","Instituto Ecuatoriano de Enfermedades Digestivas (IECED)","PRINCIPAL_INVESTIGATOR",[58,64],{"name":59,"role":60,"phone":61,"phoneExt":62,"email":63},"Miguel Puga-Tejada, MD","CONTACT","+353 87 686 0537",null,"mpuga@ieced.ec",{"name":65,"role":60,"phone":66,"phoneExt":62,"email":67},"Jorge Baquerizo-Burgos, MD","+593 98 962 7111","jorgebaquerizoburgos@gmail.com",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Instituto Ecuatoriano de Enfermedades Digestivas (IECED) Gastroclinica SA","RECRUITING","Guayaquil","Guayas","090505","Ecuador","EC",{"type":78,"coordinates":79},"Point",[80,81],-79.88621,-2.19616,{"lat":81,"lon":80},[84,86,87,89],{"name":85,"role":60,"phone":61,"phoneExt":62,"email":63},"Miguel Puga-Tejada, MD MSc",{"name":65,"role":60,"phone":66,"phoneExt":62,"email":67},{"name":88,"role":56,"phone":62,"phoneExt":62,"email":62},"Carlos Robles-Medranda, MD FASGE",{"name":90,"role":91,"phone":62,"phoneExt":62,"email":62},"Raquel Del Valle, MD","SUB_INVESTIGATOR",{"type":56,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":62,"oldOrganization":62},"Carlos Robles-Medranda","Head of the Endoscopy Division","100523997","endoscopic-ultrasound-shear-wave-for-liver-fibrosis-in-masld-patients-the-rumipamba-trial-100523997",false,"NCT06102980","Endoscopic Ultrasound Shear Wave for Liver Fibrosis in MASLD Patients: The RUMIPAMBA Trial","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","Inclusion Criteria:\n\n* Patients referred for any kind of endoscopic procedure.\n* Without clinical suspicion of advanced liver fibrosis.\n* Acceptance to participate in the study.\n\nExclusion Criteria:\n\n* History of greater amounts of alcohol per week (140 g\u002Fweek and 210 g\u002Fweek for females and males respectively).\n* Significant or advanced fibrosis by Fibrosis-4 Index (FIB4) or the aspartate aminotransferase to platelet ratio index (APRI).\n* Any liver space-occupying lesion in the US.\n* 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.","ALL","18 Years","79 Years",{"count":106,"type":107},30,"ESTIMATED","INTERVENTIONAL",[110],"NA","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.",[113,114],"Liver Steatosis","Fibrosis, Liver",[116,117,118,119,120],"Liver steatosis","Fatty liver","Endosonography","Elastography","Liver fibrosis","2024-09-22",{"date":123,"type":124},"2024-09-24","ACTUAL",{"date":126,"type":124},"2023-11-01",{"date":128,"type":107},"2025-04-01",{"name":5,"class":6},1]