[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600300":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":41,"studyPopulation":41,"armGroups":45,"interventions":56,"overallOfficials":41,"centralContacts":41,"locations":41,"responsibleParty":62,"collaborators":41,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":41,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":41,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":89,"whyStopped":41,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":41},{"fullName":5,"class":6},"Fudan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Accuracy","Using paraffin pathology as the gold standard, the accuracy of ES system and frozen pathology for AEG resection margin was evaluated: Accuracy Rate = true positive + true negative\u002Ftotal number of samples.","intraoperative",[14,18,21,23,25,27,30,33],{"measure":15,"description":16,"timeFrame":17},"Evaluation of R0 resection rate","The proportion of surgical resection specimens without residual tumor at the resection margin using paraffin pathology as the gold standard.","7days after the surgery",{"measure":19,"description":20,"timeFrame":17},"Positive margin rate","Using paraffin pathology as the gold standard, the proportion of ES interpretation as positive but frozen pathology showing negative",{"measure":22,"description":22,"timeFrame":17},"Evaluation of the actual resection margin distance during ES-assisted AEG",{"measure":24,"description":24,"timeFrame":17},"Evaluate the sensitivity, specificity, PPV, and NPV of ES technology",{"measure":26,"description":26,"timeFrame":17},"Evaluation of the consistency between ES technique and frozen pathology",{"measure":28,"description":28,"timeFrame":29},"Postoperative recurrence: evaluate the anastomotic recurrence rate at 6, 12 months, and 2 years after surgery","6, 12 months, and 2 years after surgery",{"measure":31,"description":32,"timeFrame":17},"Evaluation of the time efficiency of ES and frozen pathology","ES real-time interpretation time vs frozen pathology result time",{"measure":34,"description":34,"timeFrame":17},"Evaluate the number of timely adjustments to the resection range due to the interpretation of ES technology;",[36],{"measure":37,"description":37,"timeFrame":17},"Accuracy of ES interpretation in different Siewert classifications (type II vs. type III)",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":41,"timePerspective":41,"maskingInfo":43},"NON_RANDOMIZED","PARALLEL",null,"DIAGNOSTIC",{"masking":44,"maskingDescription":41,"whoMasked":41},"NONE",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"ES group","EXPERIMENTAL","ES-assisted surgery",[51],"Device: EndoSCell System",{"label":53,"type":54,"description":55,"interventionNames":41},"FS Group","NO_INTERVENTION","Frozen Section without ES scanning",[57],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":41},"DEVICE","EndoSCell System","EndoSCell Scaner (ES) is a new type of intraoperative cell-level fluorescence-guided imaging technology that can be used for direct and rapid intraoperative tissue cell interpretation. This technology uses a handheld cell microscope system to magnify local tissue by about 1280 times, and can perform rapid real-time scanning and imaging of in vivo or excised ex vivo tissue.",[47],{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Fenglin Liu","senior doctor","100600300","intraoperative-margin-techniques-for-esophagogastric-junction-adenocarcinoma-a-controlled-study-100600300",false,"NCT07095699","Intraoperative Margin Techniques for Esophagogastric Junction Adenocarcinoma: A Controlled Study","An Exploratory, Parallel Controlled Study to Explore the Effectiveness of Intraoperative Margin Exploration Techniques for Adenocarcinoma of the Esophagogastric Junction","Inclusion Criteria:\n\n* Patients clinically diagnosed with adenocarcinoma of the esophagogastric junction (AEG):\n\nIncluding patients with Siewert type II and III AEG; Including patients in cT1 stage (recommended esophageal resection margin distance ≥1.5cm) and cT2 and above (recommended esophageal resection margin distance ≥3cm);\n\n* Plan to receive surgical resection of AEG;\n* Patients voluntarily participated in this study and signed the informed consent form;\n\nExclusion Criteria:\n\n* Patients who are allergic to methylene blue and fluorescein sodium;\n* Patients with severe cardiovascular or circulatory system diseases and cannot tolerate surgery;\n* Participated in other clinical trials of research drugs or devices in the past month;\n* Unable to understand the test requirements or unable to complete the study follow-up plan;\n* Pregnant and lactating women;\n* Patients who are unable to complete follow-up due to mental illness, cognitive or emotional disorders;\n* Subjects who are considered by the researchers to be unsuitable for participating in the study.","ALL","18 Years","65 Years",{"count":77,"type":78},314,"ESTIMATED","INTERVENTIONAL",[81],"NA","The goal of this clinical trial is to learn if the EndoScell Scanner (ES) imaging system can accurately assess tumor-free surgical margins during surgery for adenocarcinoma of the esophagogastric junction (AEG), compared with standard frozen-section pathology.\n\nThe main questions it aims to answer are:\n\n* Is ES non-inferior to intraoperative frozen-section pathology in identifying positive or negative tumor margins?\n* Does ES shorten the time needed for margin assessment and reduce the number of additional tissue resections required?\n\nResearchers will compare an ES-assisted surgical arm with a conventional frozen-section arm to see if ES improves margin accuracy, shortens operative time, and increases the rate of complete (R0) tumor removal.\n\nParticipants will\n\n* undergo standard AEG resection with randomized assignment to either ES or frozen-section margin checks;\n* allow collection of margin tissue samples for ES, frozen-section, and final paraffin pathology;\n* attend routine follow-up visits for up to 2 years to monitor for local recurrence.",[84],"Adenocarcinoma of the Esophagogastric Junction",[86,87,88],"AEG resection","fluorescent","microscope","NOT_YET_RECRUITING","2025-07-23",{"date":92,"type":93},"2025-07-31","ACTUAL",{"date":95,"type":78},"2025-08-15",{"date":97,"type":78},"2028-06-30",{"name":5,"class":6}]