[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563306":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":58,"collaborators":19,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":19,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":19,"enrollmentInfo":70,"targetDuration":19,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":28,"whyStopped":19,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Ospedali Riuniti di Foggia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EUS-FNB","EXPERIMENTAL","Consecutive patients diagnosed with biliary strictures in absence of a pancreatic or abdominal mass will be assessed for eligibility.\n\nPatients with jaundice requiring decompression, will undergo ERCP with tissue sampling (brushing and\u002For biopsy) and biliary drainage, preferably in the same session immediately after EUS-FNB.",[13],"Device: EUS-FNB",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Endoscopic ultrasound will be performed using a curvilinear array echoendoscope. FNB with 22G or 25G end-cutting needles will be performed. The size of the needles will be based on the personal choice of the endoscopist. Likewise, the sampling technique, whether using the \"slow-pull\", the \"dry suction\", or the \"wet suction\", will be based on the physician's choice. Three passes will be performed as per current guidelines. Specimens will be collected in 3 vials to allow for analysis according to needle pass; one for the first pass, one for the second pass, and one for the third and any eventual subsequent passes.\n\nThe rapid-on site cytological evaluation (ROSE) will not be available in this study.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Antonio Facciorusso, MD PhD","CONTACT","+390881732134","antonio.facciorusso@virgilio.it",[27,43],{"facility":5,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Foggia","FG","71122","Italy","IT",{"type":35,"coordinates":36},"Point",[37,38],15.55188,41.45845,{"lat":38,"lon":37},[41],{"name":22,"role":23,"phone":42,"phoneExt":19,"email":25},"0881732134",{"facility":44,"status":28,"city":45,"state":46,"zip":47,"country":32,"countryCode":33,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Università di Verona","Verona","VR","37134",{"type":35,"coordinates":49},[50,51],10.9938,45.43854,{"lat":51,"lon":50},[54],{"name":55,"role":23,"phone":56,"phoneExt":19,"email":57},"Stefano Crinò, MD PhD","+39 0458121111","stefanocrino@hotmail.com",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Antonio Facciorusso","Associate Professor","100563306","endoscopic-ultrasound-guided-fine-needle-biopsy-for-tissue-sampling-of-biliary-strictures-a-multicenter-prospective-study-100563306",false,"NCT06614452","Endoscopic Ultrasound-guided Fine-needle Biopsy for Tissue Sampling of Biliary Strictures: a Multicenter Prospective Study","Inclusion Criteria:\n\n* Age ≥18 years\n\n  * Suspicious biliary stricture in absence of an abdominal mass at cross-sectional imaging\n  * Distal and peri-hilar biliary strictures\n  * Informed consent provided by the patient or the closest relative\n\nExclusion Criteria:\n\n* Presence of a pancreatic or abdominal mass structuring the common bile duct\n\n  * EUS not feasible\n  * Known bleeding disorder that cannot be sufficiently corrected with fresh frozen plasma (FFP)\n  * Use of anticoagulants that cannot be discontinued\n  * INR \\>1.5 or platelet count \\<50.000\n  * Pregnancy","ALL","18 Years",{"count":71,"type":72},45,"ESTIMATED","INTERVENTIONAL",[75],"NA","After the disappointing results of first-generation reverse bevel fine-needle biopsy (FNB) needles, newer 'third generation' endoscopic ultrasound (EUS) needles were developed, known as the \"end-cutting\" needles. These needle types have shown excellent diagnostic accuracy (\\>90%) in pancreatic masses and several other lesions, even without rapid on site evaluation (ROSE) and are not associated with increased adverse event incidence . The main design of end-cutting FNB needles are the Franseen type, which has three symmetrically distributed needle points and cutting edges, and the Fork-tip type which has 2 protruding asymmetrical sharp points and six distal cutting edges; however, other end-cutting needles are currently available such as the three-prong asymmetric tip needle and the Menghini tip needle.\n\nGiven the significant increase in diagnostic accuracy and sensitivity observed in other abdominal lesions, these needles are expected to improve the diagnostic outcomes of EUS-FNB of \"pure\" biliary strictures although clinical data are still lacking.\n\nThe aim of this study is to ascertain the impact of end-cutting FNB needles in the diagnostic algorithm of biliary strictures in absence of a clear pancreatic or abdominal mass.\n\nThis is a multicenter international observational prospective study. Consecutive patients diagnosed with biliary strictures in absence of a pancreatic or abdominal mass will be assessed for eligibility.\n\nPatients with jaundice requiring decompression, will undergo endoscopic retrograde cholangiopancreatography (ERCP) with tissue sampling (brushing and\u002For biopsy) and biliary drainage, preferably in the same session immediately after EUS-FNB.\n\nEndoscopic ultrasound will be performed using a curvilinear array echoendoscope. FNB with 22G or 25G end-cutting needles will be performed. The size of the needles will be based on the personal choice of the endoscopist. Likewise, the sampling technique, whether using the \"slow-pull\", the \"dry suction\", or the \"wet suction\", will be based on the physician's choice. Three passes will be performed as per current guidelines. Specimens will be collected in 3 vials to allow for analysis according to needle pass; one for the first pass, one for the second pass, and one for the third and any eventual subsequent passes.\n\nThe ROSE will not be available in this study. Primary outcome will be diagnostic sensitivity of EUS-FNB and 45 patients will be prospectically enrolled.",[78],"Biliary Strictures",[80,9,81],"biliary strictures","Cancer","2024-09-25",{"date":84,"type":85},"2024-09-26","ACTUAL",{"date":87,"type":85},"2024-09-10",{"date":89,"type":72},"2025-10-20",{"name":5,"class":6},2]