[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647894":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":35,"locations":41,"responsibleParty":67,"collaborators":10,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":10,"enrollmentInfo":80,"targetDuration":83,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":94,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal FibroScan Cohort",null,"Adults aged 18 years or older undergoing clinically indicated diagnostic endoscopic ultrasound (EUS) for non-hepatobiliary indications who have normal FibroScan findings (Controlled Attenuation Parameter \\[CAP\\] \\\u003C238 dB\u002Fm and Liver Stiffness Measurement \\[LSM\\] \\\u003C7.5 kPa). Participants will undergo EUS-guided Attenuation Imaging (ATI) and Shear Wave Elastography (SWE) of the right and left hepatic lobes during the same EUS procedure to establish preliminary reference values and assess the feasibility and reliability of these quantitative imaging techniques.",[13,14,15,16],"Procedure: Endoscopic Ultrasound (EUS)","Procedure: EUS-guided Attenuation Imaging (ATI)","Procedure: EUS-Guided Shear Wave Elastography (SWE)","Procedure: FibroScan",[18,23,27,31],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"PROCEDURE","Endoscopic Ultrasound (EUS)","A clinically indicated diagnostic endoscopic ultrasound will be performed according to standard institutional practice. During the examination, the liver will be visualized from the stomach and duodenum to allow quantitative liver assessment.",[9],{"type":19,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"EUS-guided Attenuation Imaging (ATI)","Attenuation Imaging (ATI) will be performed during the diagnostic EUS to quantitatively assess hepatic steatosis. Five valid ATI measurements will be obtained from both the right and left hepatic lobes under direct EUS visualization. Measurements meeting predefined quality criteria will be used for analysis.",[9],{"type":19,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"EUS-Guided Shear Wave Elastography (SWE)","Shear Wave Elastography (SWE) will be performed during the diagnostic EUS to assess liver stiffness. Ten valid measurements will be obtained from both the right and left hepatic lobes. Shear wave velocity (m\u002Fs) and tissue elasticity (kPa) will be recorded, and only measurements meeting predefined quality criteria will be included in the analysis.",[9],{"type":19,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"FibroScan","Participants will undergo same-day FibroScan examination before EUS to confirm normal liver stiffness and steatosis. Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM) will be recorded, with at least 10 valid measurements and acceptable quality metrics required for study eligibility.",[9],[36],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Aig research","CONTACT","+919182645727","aigresearch7@gmail.com",[42],{"facility":43,"status":10,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"AIG Hospitals","Hyderabad","Telangana","500032","India","IN",{"type":50,"coordinates":51},"Point",[52,53],78.45636,17.38405,{"lat":53,"lon":52},[56,59,62,65],{"name":57,"role":38,"phone":58,"phoneExt":10,"email":40},"Aig research, MD, DM","09182645727",{"name":60,"role":61,"phone":10,"phoneExt":10,"email":10},"Dr. Sundeep Lakhtakia, MD, DM","PRINCIPAL_INVESTIGATOR",{"name":63,"role":64,"phone":10,"phoneExt":10,"email":10},"Dr. Anudeep Katrevula, MD, DM","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":10,"phoneExt":10,"email":10},"Dr. Jahangeer Basha, MD, DM",{"type":61,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Mohan Ramchandani","Consultant Gastroenterology","100647894","eus-guided-ati-and-swe-in-individuals-with-normal-fibroscan-100647894",false,"NCT07714941","EUS-Guided ATI and SWE in Individuals With Normal FibroScan","\"EUS-Guided Attenuation Imaging and Shear Wave Elastography in Individuals With Normal FibroScan: Establishing Preliminary Reference Values in a Pilot Feasibility Study\".","EUS ATI&SWE","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Undergoing clinically indicated diagnostic endoscopic ultrasound (EUS).\n* Same-day FibroScan examination available.\n* Controlled Attenuation Parameter (CAP) \\\u003C238 dB\u002Fm.\n* Liver Stiffness Measurement (LSM) \\\u003C7.5 kPa.\n* At least 10 valid FibroScan measurements.\n* FibroScan interquartile range (IQR)\u002Fmedian ≤30%.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Known chronic liver disease.\n* Hepatitis B or Hepatitis C infection.\n* Significant alcohol consumption.\n* Decompensated cirrhosis.\n* Portal vein thrombosis.\n* Ascites.\n* Focal liver lesion.\n* Previous liver surgery.\n* Pregnancy.\n* Inadequate FibroScan examination.\n* Poor-quality EUS-guided Attenuation Imaging (ATI) or Shear Wave Elastography (SWE) acquisition.\n* Incomplete study data or withdrawal of informed consent.","ALL","18 Years",{"count":81,"type":82},100,"ESTIMATED","1 Day","OBSERVATIONAL","The goal of this observational study is to establish preliminary reference values for Endoscopic Ultrasound (EUS)-guided Attenuation Imaging (ATI) and Shear Wave Elastography (SWE) in adults undergoing diagnostic EUS for non-hepatobiliary indications who have normal FibroScan findings. The main questions it aims to answer are:\n\nWhat are the preliminary normal reference values for EUS-guided ATI in the right and left hepatic lobes? What are the preliminary normal reference values for EUS-guided SWE elasticity (kPa) and velocity (m\u002Fs) in the right and left hepatic lobes?\n\nParticipants will:\n\nUndergo same-day FibroScan assessment to confirm normal liver stiffness and steatosis parameters.\n\nUndergo EUS-guided ATI and SWE measurements of both the right and left hepatic lobes during their clinically indicated diagnostic EUS examination.\n\nHave demographic, clinical, and laboratory information recorded for analysis.",[87],"Non-hepatobiliary Indications",[20,89,90,91,92,93],"Attenuation Imaging (ATI)","Shear Wave Elastography (SWE)","Liver Fibrosis","Controlled Attenuation Parameter (CAP)","Liver Stiffness Measurement (LSM)","NOT_YET_RECRUITING","2026-07-15",{"date":97,"type":98},"2026-07-20","ACTUAL",{"date":100,"type":82},"2026-08-20",{"date":102,"type":82},"2027-09-20",{"name":5,"class":6},1]