[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634713":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":45,"studyPopulation":46,"armGroups":47,"interventions":53,"overallOfficials":41,"centralContacts":59,"locations":65,"responsibleParty":81,"collaborators":83,"id":103,"slug":41,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":41,"eligibilityCriteria":107,"healthyVolunteers":104,"sex":108,"minAge":109,"maxAge":41,"enrollmentInfo":110,"targetDuration":41,"studyType":113,"phases":41,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":121,"whyStopped":41,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Qilu Hospital of Shandong University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":41},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"The accuracy of iEUS-PCL for pancreatic cystic lesions","The primary outcome of the study is to evaluate the accuracy of the iEUS-PCL in identifying the pancreatic cystic lesions (benign\u002Fmalignant; mucinous\u002Fnon-mucinous; 4-category).","During procedure",{"measure":14,"description":15,"timeFrame":12},"The sensitivity of iEUS-PCL for pancreatic cystic lesions","The primary outcome of the study is to evaluate the sensitivity of the iEUS-PCL in identifying the pancreatic cystic lesions (benign\u002Fmalignant; mucinous\u002Fnon-mucinous; 4-category).",{"measure":17,"description":18,"timeFrame":12},"The specificicy of iEUS-PCL for pancreatic cystic lesions","The primary outcome of the study is to evaluate the specificity of the iEUS-PCL in identifying the pancreatic cystic lesions (benign\u002Fmalignant; mucinous\u002Fnon-mucinous; 4-category).",{"measure":20,"description":21,"timeFrame":12},"The postive predictive value of iEUS-PCL for pancreatic cystic lesions","The primary outcome of the study is to evaluate the postive predictive value of the iEUS-PCL in identifying the pancreatic cystic lesions (benign\u002Fmalignant; mucinous\u002Fnon-mucinous; 4-category).",{"measure":23,"description":24,"timeFrame":12},"The negative predictive value of iEUS-PCL for pancreatic cystic lesions","The primary outcome of the study is to evaluate the negative predictive value of the iEUS-PCL in identifying the pancreatic cystic lesions (benign\u002Fmalignant; mucinous\u002Fnon-mucinous; 4-category).",[26,29,32,35,38],{"measure":27,"description":28,"timeFrame":12},"Comparison of the accuracy between iEUS-PCL and endosonographers","The secondary outcome of the study is to comparing the accuracy between iEUS-PCL and different-level endosonographers in identifying the pancreatic cystic lesions (benign\u002Fmalignant; mucinous\u002Fnon-mucinous; 4-category).",{"measure":30,"description":31,"timeFrame":12},"Comparison of the sensitivity between iEUS-PCL and endosonographers","The secondary outcome of the study is to comparing the sensitivity between iEUS-PCL and different-level endosonographers in identifying in identifying the pancreatic cystic lesions (benign\u002Fmalignant; mucinous\u002Fnon-mucinous; 4-category).",{"measure":33,"description":34,"timeFrame":12},"Comparison of the specificity between iEUS-PCL and endosonographers","The secondary outcome of the study is to comparing the specificity between iEUS-PCL and different-level endosonographers in identifying in identifying the pancreatic cystic lesions (benign\u002Fmalignant; mucinous\u002Fnon-mucinous; 4-category).",{"measure":36,"description":37,"timeFrame":12},"Comparison of the postive predictive value between iEUS-PCL and endosonographers","The secondary outcome of the study is to comparing the postive predictive value between iEUS-PCL and different level endosonographers in identifying in identifying the pancreatic cystic lesions (benign\u002Fmalignant; mucinous\u002Fnon-mucinous; 4-category).",{"measure":39,"description":40,"timeFrame":12},"Comparison of the negative predictive value between iEUS-PCL and endosonographers","The secondary outcome of the study is to comparing the negative predictive value between iEUS-PCL and different-level endosonographers in identifying in identifying the pancreatic cystic lesions (benign\u002Fmalignant; mucinous\u002Fnon-mucinous; 4-category).",null,{"allocation":41,"interventionModel":41,"interventionModelDescription":41,"primaryPurpose":41,"observationalModel":43,"timePerspective":44,"maskingInfo":41},"COHORT","PROSPECTIVE","This multicenter, prospective cohort study aims to develop and validate a multimodal artificial intelligence system named iEUS-PCL for the detection and differential diagnosis of PCL. The model was developed based on retrospectively collected EUS images, EUS features, clinical data and radiological imaging features of patients who underwent EUS examination. The diagnostic performance of iEUS-PCL will be evaluated prospectively in real-time EUS videos and compared with endosonographers' performance.","Adult patients with suspected pancreatic cystic lesions undergoing EUS.",[48],{"label":49,"type":41,"description":50,"interventionNames":51},"Patients undergoing EUS","Patients aged ≥18 years scheduled for EUS with suspected pancreatic cystic lesions based on clinical symptoms, medical history, laboratory tests or radiological examinations are eligible upon agreement to participate in the research and voluntary signing of the informed consent.",[52],"Device: iEUS-PCL(intelligent endoscopic ultrasound system- pancreatic cystic lesion)",[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":41},"DEVICE","iEUS-PCL(intelligent endoscopic ultrasound system- pancreatic cystic lesion)","The iEUS-PCL will automatically detect pancreatic cystic lesions and integrate the patients' EUS images, EUS features, clinical data and radiological imaging features to perform three classification tasks:\n\n1. binary classification: benign\u002Fmalignant lesions;\n2. binary classification: mucinous\u002Fnon-mucinous lesions;\n3. four-category classification: intraductal papillary mucinous neoplasm\u002F mucinous cystic neoplasm\u002F serous cyst neoplasm\u002F pancreatic cyst.",[49],[60],{"name":61,"role":62,"phone":63,"phoneExt":41,"email":64},"Zhen Li","CONTACT","86+18560086106","qilulizhen@sdu.edu.cn",[66],{"facility":5,"status":41,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Jinan","Shandong","250012","China","CN",{"type":73,"coordinates":74},"Point",[75,76],116.99722,36.66833,{"lat":76,"lon":75},[79],{"name":80,"role":62,"phone":63,"phoneExt":41,"email":64},"Zhen Li, doctor",{"type":82,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[84,86,88,90,92,95,97,99,101],{"name":85,"class":6},"Liaocheng People's Hospital",{"name":87,"class":6},"Taian City Central Hospital",{"name":89,"class":6},"Qilu Hospital of Shandong University (Qingdao)",{"name":91,"class":6},"Binzhou People's Hospital",{"name":93,"class":94},"Shandong Provincial Hospital","OTHER_GOV",{"name":96,"class":6},"The Affiliated Hospital of Qingdao University",{"name":98,"class":6},"Qianfoshan Hospital",{"name":100,"class":6},"Shengli Oilfield Hospital",{"name":102,"class":6},"Binzhou Medical University","100634713",false,"NCT07543263","An Artificial Intelligence System for Multimodal, Multi-class Diagnosis of Pancreatic Cystic Lesions Based on Endoscopic Ultrasonography","Inclusion Criteria:\n\n\\- 1. Patients aged ≥18 years scheduled for EUS with suspected pancreatic cystic lesions based on clinical symptoms, medical history, laboratory tests or radiological examinations, and who agree to participate in the research and voluntarily sign the informed consent.\n\n2\\. Patients with no prior history of treatment for pancreatic lesions.\n\nExclusion Criteria:\n\n\\- 1. Patients with absolute contraindications to EUS examination. 2. Pregnancy or lactating. 3. Uncorrectable coagulopathy(PTT\\>50 seconds or INR\\>1.5) and\u002For uncorrectable thrombocytopenia(platelet count\\\u003C50×109\u002FL). 4. Upper gastrointestinal obstruction. 5. Patients who underwent surgical treatment or anatomical alterations of the pancreas due to lesions in other thoracic and\u002For abdominal organs, as well as patients with congenital anatomical abnormalities.\n\n6\\. Patients who have undergone biliary\u002Fpancreatic duct stent placement. 7. Patients who refuse to sign the informed consent.","ALL","18 Years",{"count":111,"type":112},176,"ESTIMATED","OBSERVATIONAL","The aim of this study is to develop and validate an artificial intelligence system named iEUS-PCL (intelligent endoscopic ultrasound system-pancreatic cystic lesions） for detecting and multimodal, multi-class diagnosing pancreatic cystic lesions (PCL) during endoscopic ultrasound (EUS) examination.",[116],"Pancreatic Cystic Lesion (PCL)",[118,119,120],"endoscopic ultrasound","pancreatic cystic lesion","machine learning","NOT_YET_RECRUITING","2026-04-23",{"date":124,"type":125},"2026-04-29","ACTUAL",{"date":127,"type":112},"2026-04-20",{"date":129,"type":112},"2028-06-30",{"name":5,"class":6},1]