[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592529":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":58,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":85,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Changhai Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MOSE group","EXPERIMENTAL","Patients assigned to this group will receive EUS-FNB as routine. The obtained tissue will be evaluated by Macroscopic On-site Evaluation",[13],"Procedure: MOSE application",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-mose group","ACTIVE_COMPARATOR","Patients assigned to this group will receive EUS-FNB as routine. Two needles were punctured and all tissue strips were placed into bottle A formalin.",[19],"Procedure: Conventional processing",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","MOSE application","The length of the tissue strips was judged using the specimen table and photographed for record. If the MVC of the first needle sample was ≥10mm, the tissue strip was placed into bottle A formalin for fixation. A second needle of tissue strip was pushed directly into the B-bottle formalin. If the first needle sample MVC was \\\u003C 10mm, the puncture was continued until the total length of sample MVC was ≥10mm, and all samples were placed into bottle A formalin.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional processing","Two needles were punctured and all tissue strips were placed into bottle A formalin.",[15],[32],{"name":33,"affiliation":34,"role":35},"Zhao Shen Li, M.D","Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), shanghai, China","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Jia Yi Ma, M.D","CONTACT","+8613621819595","504043536@qq.com",{"name":43,"role":39,"phone":26,"phoneExt":26,"email":44},"Kai Xuan Wang, M.D","wangkaixuan224007@163.com",[46],{"facility":5,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":26},"Shanghai","Shanghai Municipality","200433","China","CN",{"type":53,"coordinates":54},"Point",[55,56],121.45806,31.22222,{"lat":56,"lon":55},{"type":35,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Zhaoshen Li","Department of Gastroenterology, Changhai Hospital","100592529","fine-needle-biopsy-combined-with-macroscopic-on-site-evaluation-for-diagnosis-of-solid-pancreatic-lesions-100592529",false,"NCT06994611","Fine-needle Biopsy Combined With Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions","Endoscopic Ultrasound-guided Fine-needle Biopsy With or Without Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Prospective Multicenter Randomized Controlled Non-Inferiority Trial","Inclusion Criteria:\n\n* (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)\n\n  1. 18-80 years old (inclusive), male and female;\n  2. patients with pancreatic solid mass \\> 1cm detected by CT\u002FMRI\u002FPET-CT or EUS and requiring EUS-FNB diagnosis.\n  3. written informed consent was obtained;\n\nExclusion Criteria:\n\n* (Before the trial, participants could not be enrolled if they met any of the following requirements)\n\n  1. contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;\n  2. bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;\n  3. confirmed pregnancy or possible pregnancy;\n  4. pathological diagnosis has been obtained by other methods;\n  5. refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days.\n  6. other situations where EUS-FNB could not be performed.","ALL","18 Years","80 Years",{"count":72,"type":73},148,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this clinical trial is to compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time of macroscopic on-site evaluation (MOSE) and two punctures alone in Endoscopic ultrasound guided fine-needle biopsy (EUS-FNB) for solid pancreatic lesions. The main questions it aims to answer is: whether the diagnostic accuracy of EUS-FNB performed with two needle passes is not inferior to that of MOSE.\n\nParticipants with solid pancreatic lesions who needs histological diagnosis will receive EUS-FNB using 22G Franseen.\n\nIn Group 1, the macroscopically visible core (MVC) of the specimen was assessed. If the MVC of the sample obtained from the first needle was ≥10mm, the tissue strip was placed in Bottle A and fixed with formalin. A second needle was then used to obtain another tissue strip, which was directly placed into Bottle B containing formalin. However, if the MVC of the first needle sample was \\\u003C 10mm, the puncture procedure was continued until the cumulative length of sample's MVC was ≥10mm, and all the sample collected during this process were placed into Bottle A and fixed with formalin. In Group 2, two needles were used to obtain tissue strips, and all the tissue strips were placed into Bottle A formalin.\n\nResearchers will compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time between the MOSE technique and two-needle puncture method.",[79],"Pancreatic Diseases",[81,82,83,84],"EUS-FNB","solid pancreatic lesion","sample processing","22D Franseen Needle","NOT_YET_RECRUITING","2025-06-05",{"date":88,"type":89},"2025-06-06","ACTUAL",{"date":91,"type":73},"2025-06-25",{"date":93,"type":73},"2026-08-26",{"name":5,"class":6},1]