[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557236":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":61,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":10,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":83,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Société Française d'Endoscopie Digestive","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"EUS-FNA for PCL with ATBp",null,"Patients undergoing EUS-FNA for pancreatic cystic lesions WITH ATBp",[13,14],"Procedure: EUS-FNA","Drug: ATBp",{"label":16,"type":10,"description":17,"interventionNames":18},"EUS-FNA for PCL without ATBp","Patients undergoing EUS-FNA for pancreatic cystic lesions without ATBp",[13],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","EUS-FNA","Puncture of pancreatic cystic lesion with a fine needle under EUS guidance",[9,16],[26],"EUS fine needle aspiration",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","ATBp","Antibiotic prophylaxis consists of a single intravenous administration before or at the beginning of the procedure according to the common practices of each practitioner or unit",[9],[33],"Antibiotic prophylaxis",[35],{"name":36,"affiliation":37,"role":38},"David KARSENTI","Societe Française d'Endoscopie Digestive","STUDY_CHAIR",[40],{"name":41,"role":42,"phone":43,"phoneExt":10,"email":44},"David KARSENTI, MD","CONTACT","+33 1 43 96 78 50","karsenti.paris@gmail.com",[46],{"facility":47,"status":10,"city":48,"state":10,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Clinique Paris-Bercy","Charenton-le-Pont","94220","France","FR",{"type":53,"coordinates":54},"Point",[55,56],2.41217,48.82209,{"lat":56,"lon":55},[59],{"name":41,"role":42,"phone":60,"phoneExt":10,"email":44},"+33143967850",{"type":62,"investigatorFullName":36,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Medical doctor, Principal Investigator","100557236","antibiotic-prophylaxis-for-eus-fna-of-pancreatic-cystic-lesions-100557236",false,"NCT06535490","Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions","Prevention of Infection After EUS-FNA of Pancreatic Cystic Lesions: A French Multicenter Prospective Comparative Observational Study","PrePaCyst","Inclusion Criteria:\n\n* Patient referred for diagnostic aspiration of a pancreatic cystic lesion\n* Patient aged 18 years or older\n* Patient with ASA 1, ASA 2, ASA 3 status\n* No participation in another concurrent clinical study\n\nExclusion Criteria:\n\n* Patient under 18 years old\n* Patient with ASA 4 or ASA 5 status\n* Pregnant woman\n* Patient with coagulation disorders preventing the performance of an EUS-FNA: PT \\\u003C 50%, platelets \\\u003C 50,000\u002Fmm³, current effective anticoagulation, ongoing clopidogrel, prasugrel, or ticagrelor treatment\n* Patient unable to personally express non-opposition or legally protected adult","ALL","18 Years",{"count":75,"type":76},1702,"ESTIMATED","OBSERVATIONAL","Large prospective comparative observational study in numerous reference centers in France, comparing infectious complications in patients admitted for pancreatic cystic lesions (PCL) aspiration performed with or without antibiotic prophylaxis (ATBp) according to the usual practices.\n\nThis is a prospective, comparative, observational, multicenter study, with the primary objective of comparing the infection rates in pancreatic cystic lesions (PCL) aspirated under EUS, with and without the administration of ATBp.\n\nA sample size of 1702 patients will be needed over a 3-year study period.",[80],"Pancreatic Cystic Lesion",[22,82,33],"Pancreatic cystic lesion","NOT_YET_RECRUITING","2024-08-01",{"date":86,"type":87},"2024-08-02","ACTUAL",{"date":89,"type":76},"2024-09-15",{"date":91,"type":76},"2027-10-15",{"name":5,"class":6},1]